Z-0411-2019Class II

Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH...

Name: Z-0411-2019 Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH...
Creator: GE Healthcare, LLC
Published: 2018-09-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-09-27 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS... on 2018-09-27. FDA classified it as Class II and gives the reason as "Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0411-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-27
Posted: 2018-11-09
Terminated: 2021-04-12
Recalling firm: GE Healthcare
Product: Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare notified customers on about 09/27/2018 via "URGENT MEDICAL DEVICE CORRECTION" letter. The letter informed customers that they could continue to use the anesthesia device. The issue can only occur if the patient stops spontaneous breathing in PSVPro ventilation mode after completion of lung recruitment breaths. Stopping the Cycling Procedure resolves the issue. Continue to monitor patient as is normal for Apnea. A GE Healthcare representative will contact each customer to arrange for the correction. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 4,207 units total
Distribution: Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Product codes and lots: Model Number, UDI Number, (Serial Number): 2097674-001-US, Not Applicable, (5470345-30); 2097674-001-US, Not Applicable, (5470345-31); 2097674-001-US, Not Applicable, (5470345-32); 1011-9000-000, Not Applicable, (ANAK00774); 1011-9000-000, Not Applicable, (ANAK00775); 1011-9000-000, Not Applicable, (ANAL01201); 1011-9000-000, Not Applicable, (ANAL01234); 1011-9000-000, Not Applicable, (ANAL01235); 1011-9000-000, Not Applicable, (ANAL01236); 1011-9000-000, Not Applicable, (ANAL01237); 1011-9000-000, Not Applicable, (ANAL01238); 1011-9000-000, Not Applicable, (ANAL01240); 1011-9000-000, Not Applicable, (ANAL01494); 1011-9000-000, Not Applicable, (ANAL01495); 1011-9000-000, Not Applicable, (ANAL01551); 1011-9000-000, Not Applicable, (ANAM01023); 1011-9000-000, Not Applicable, (ANAM01024); 1011-9000-000, Not Applicable, (ANAM01025); 1011-9000-000, Not Applicable, (ANAM01026); 1011-9000-000, Not Applicable, (ANAM01027); 1011-9000-000, Not Applicable, (ANAM01104); 1011-9000-000, Not Applicable, (ANAM01105); 1011-9000-000, Not Applicable, (ANAP00438); 1011-9000-000, Not Applicable, (ANAP00439); 1011-9000-000, Not Applicable, (ANAQ01188); 1011-9000-000, Not Applicable, (ANAR05264); 1011-9000-000, Not Applicable, (ANAR05265); 1011-9000-000, Not Applicable, (ANAR05610); 1011-9000-000, Not Applicable, (ANAR05611); 1011-9000-000, Not Applicable, (ANAS00202); 1011-9000-000, Not Applicable, (ANAS00203); 1011-9000-000, Not Applicable, (ANAS00204); 2097674-001-US, Not Applicable, (5479630-1); ANAK00798, Not Applicable (1011-9000-000); ANAK00799, Not Applicable (1011-9000-000); ANAK00803, Not Applicable (1011-9000-000); ANAK00807, Not Applicable (1011-9000-000); ANAK00814, Not Applicable (1011-9000-000); ANAK00839, Not Applicable (1011-9000-000); ANAK00864, Not Applicable (1011-9000-000); 5481223-1, Not Applicable (2097674-001-US); 5481223-10, Not Applicable (2097674-001-US); 5481223-11, Not Applicable (2097674-001-US); 5481223-12, Not Applicable (2097674-001-US); 5481223-2, Not Applicable (2097674-001-US); 5481223-3, Not Applicable (2097674-001-US); 5481223-4, Not Applicable (2097674-001-US); 5481223-5, Not Applicable (2097674-001-US); 5481223-6, Not Applicable (2097674-001-US); 5481223-7, Not Applicable (2097674-001-US); 5481223-8, Not Applicable (2097674-001-US); 5481223-9, Not Applicable (2097674-001-US); ANAP00712, Not Applicable (1011-9000-000); ANAP00713, Not Applicable (1011-9000-000); ANAP00714, Not Applicable (1011-9000-000); ANAN01125, Not Applicable (1011-9000-000); ANAN01138, Not Applicable (1011-9000-000); 4652664-1, Not Applicable (2097674-001-US); 4652664-10, Not Applicable (2097674-001-US); 4652664-11, Not Applicable (2097674-001-US); 4652664-12, Not Applicable (2097674-001-US); 4652664-13, Not Applicable (2097674-001-US); 4652664-2, Not Applicable (2097674-001-US); 4652664-3, Not Applicable (2097674-001-US); 4652664-4, Not Applicable (2097674-001-US); 4652664-5, Not Applicable (2097674-001-US); 4652664-6, Not Applicable (2097674-001-US); 4652664-7, Not Applicable (2097674-001-US); 4652664-8, Not Applicable (2097674-001-US); 4652664-9, Not Applicable (2097674-001-US); ANAK00156, Not Applicable (1011-9000-000); ANAK00157, Not Applicable (1011-9000-000); ANAK00158, Not Applicable (1011-9000-000); ANAK00159, Not Applicable (1011-9000-000); ANAK00511, Not Applicable (1011-9000-000); ANAK00512, Not Applicable (1011-9000-000); ANAK00513, Not Applicable (1011-9000-000); ANAK00514, Not Applicable (1011-9000-000); ANAN01051, Not Applicable (1011-9000-000); ANAN01052, Not Applicable (1011-9000-000); ANAP00545, Not Applicable (1011-9000-000); ANAP00546, Not Applicable (1011-9000-000); ANAP00708, Not Applicable (1011-9000-000); ANAL01400, Not Applicable (1011-9000-000); ANAL01401, Not Applicable (1011-9000-000); ANAM00449, Not Applicable (1011-9000-000); ANAM01089, Not Applicable (1011-9000-000); 5453450-1, Not Applicable (2097674-001); 5453450-2, Not Applicable (2097674-001); 5453450-3, Not Applicable (2097674-001); 5453450-4, Not Applicable (2097674-001); 5453450-5, Not Applicable (2097674-001); 5453450-6, Not Applicable (2097674-001); 5453450-7, Not Applicable (2097674-001); 5453450-8, Not Applicable (2097674-001); 5480532-1, Not Applicable (2097674-001); 5447751-1, Not Applicable (2097674-001); 5447751-10, Not Applicable (2097674-001); 5447751-11, Not Applicable (2097674-001); 5447751-12, Not Applicable (2097674-001); 5447751-13, Not Applicable (2097674-001); 5447751-14, Not Applicable (2097674-001); 5447751-15, Not Applicable (2097674-001); 5447751-16, Not Applicable (2097674-001); 5447751-17, Not Applicable (2097674-001); 5447751-18, Not Applicable (2097674-001); 5447751-19, Not Applicable (2097674-001); 5447751-2, Not Applicable (2097674-001); 5447751-20, Not Applicable (2097674-001); 5447751-21, Not Applicable (2097674-001); 5447751-22, Not Applicable (2097674-001); 5447751-23, Not Applicable (2097674-001); 5447751-24, Not Applicable (2097674-001); 5447751-3, Not Applicable (2097674-001); 5447751-4, Not Applicable (2097674-001); 5447751-5, Not Applicable (2097674-001); 5447751-6, Not Applicable (2097674-001); 5447751-7, Not Applicable (2097674-001); 5447751-8, Not Applicable (2097674-001); 5447751-9, Not Applicable (2097674-001); 5452649-1, Not Applicable (2097674-001); 5452649-2, Not Applicable (2097674-001); 5474323-1, Not Applicable (2097674-DE); ANAR05021, Not Applicable (1011-9000-000); 5473625-5, Not Applicable (2097674-NL); 5473625-6, Not Applicable (2097674-NL); 5473625-7, Not Applicable (2097674-NL); ANAK00330, Not Applicable (1011-9000-000); ANAK00332, Not Applicable (1011-9000-000); ANAK00334, Not Applicable (1011-9000-000); ANAL00806, Not Applicable (1011-9000-000); ANAL00807, Not Applicable (1011-9000-000); ANAL00808, Not Applicable (1011-9000-000); ANAL00809, Not Applicable (1011-9000-000); ANAN01010, Not Applicable (1011-9000-000); ANAN01011, Not Applicable (1011-9000-000); ANAN01012, Not Applicable (1011-9000-000); ANAN01013, Not Applicable (1011-9000-000); ANAN01014, Not Applicable (1011-9000-000); ANAP00399, Not Applicable (1011-9000-000); ANAP01133, Not Applicable (1011-9000-000); ANAR00344, Not Applicable (1011-9000-000); ANAR00896, Not Applicable (1011-9000-000); ANAR05978, Not Applicable (1011-9000-000); ANAR05979, Not Applicable (1011-9000-000); ANAR05980, Not Applicable (1011-9000-000); ANAR05981, Not Applicable (1011-9000-000); ANAR05982, Not Applicable (1011-9000-000); ANAR05983, Not Applicable (1011-9000-000); ANAR05984, Not Applicable (1011-9000-000); ANAS00709, Not Applicable (1011-9000-000); ANAS00710, Not Applicable (1011-9000-000); ANAS00711, Not Applicable (1011-9000-000); 5472401-2, Not Applicable (2097674-001); ANAP00132, Not Applicable (1011-9000-000); 5472557-4, Not Applicable (2097674-001); 5472557-5, Not Applicable (2097674-001); 5472557-6, Not Applicable (2097674-001); ANAN01045, Not Applicable (1011-9000-000); ANAN01046, Not Applicable (1011-9000-000); ANAR00327, Not Applicable (1011-9000-000); ANAS00345, Not Applicable (1011-9000-000); 5454764-3, Not Applicable (2097674-001); ANAP00584, Not Applicable (1011-9000-000); ANAP00585, Not Applicable (1011-9000-000); ANAP00586, Not Applicable (1011-9000-000); ANAP00587, Not Applicable (1011-9000-000); ANAP00588, Not Applicable (1011-9000-000); ANAP00589, Not Applicable (1011-9000-000); ANAP00825, Not Applicable (1011-9000-000); ANAP01215, Not Applicable (1011-9000-000); ANAS00738, Not Applicable (1011-9000-000); ANAL01390, Not Applicable (1011-9000-000); ANAL01391, Not Applicable (1011-9000-000); ANAS00391, Not Applicable (1011-9000-000); ANAR00492, Not Applicable (1011-9000-000); ANAR00493, Not Applicable (1011-9000-000); ANAR00494, Not Applicable (1011-9000-000); ANAR00495, Not Applicable (1011-9000-000); ANAR00496, Not Applicable (1011-9000-000); ANAR00497, Not Applicable (1011-9000-000); ANAR00498, Not Applicable (1011-9000-000); ANAR00499, Not Applicable (1011-9000-000); ANAR00500, Not Applicable (1011-9000-000); ANAR00501, Not Applicable (1011-9000-000); ANAR00756, Not Applicable (1011-9000-000); ANAR00757, Not Applicable (1011-9000-000); ANAL00705, Not Applicable (1011-9000-000); ANAL01040, Not Applicable (1011-9000-000); ANAL01041, Not Applicable (1011-9000-000); ANAL01042, Not Applicable (1011-9000-000); ANAL01043, Not Applicable (1011-9000-000); ANAL01044, Not Applicable (1011-9000-000); ANAL01045, Not Applicable (1011-9000-000); ANAL01046, Not Applicable (1011-9000-000); ANAL01047, Not Applicable (1011-9000-000); ANAL01048, Not Applicable (1011-9000-000); ANAL01050, Not Applicable (1011-9000-000); ANAM00335, Not Applicable (1011-9000-000); ANAL00192, Not Applicable (1011-9000-000); ANAL00754, Not Applicable (1011-9000-000); ANAL00755, Not Applicable (1011-9000-000); ANAL00756, Not Applicable (1011-9000-000); ANAL00757, Not Applicable (1011-9000-000); ANAL00764, Not Applicable (1011-9000-000); ANAL00769, Not Applicable (1011-9000-000); ANAL00776, Not Applicable (1011-9000-000); ANAL00777, Not Applicable (1011-9000-000); ANAL00778, Not Applicable (1011-9000-000); ANAL00779, Not Applicable (1011-9000-000); ANAL00780, Not Applicable (1011-9000-000); ANAL00781, Not Applicable (1011-9000-000); ANAL00782, Not Applicable (1011-9000-000); ANAL00783, Not Applicable (1011-9000-000); ANAL00784, Not Applicable (1011-9000-000); ANAL00785, Not Applicable (1011-9000-000); ANAL00786, Not Applicable (1011-9000-000); ANAL00787, Not Applicable (1011-9000-000); ANAL00788, Not Applicable (1011-9000-000); ANAL00789, Not Applicable (1011-9000-000); ANAL00790, Not Applicable (1011-9000-000); ANAL00791, Not Applicable (1011-9000-000); ANAL00792, Not Applicable (1011-9000-000); ANAL01541, Not Applicable (1011-9000-000); ANAL01542, Not Applicable (1011-9000-000); ANAP00810, Not Applicable (1011-9000-000); ANAP00811, Not Applicable (1011-9000-000); ANAS00938, Not Applicable (1011-9000-000); ANAP01070, Not Applicable (1011-9000-000); 5473409-1, Not Applicable (2097674-FR); 5473409-2, Not Applicable (2097674-FR); 5473409-3, Not Applicable (2097674-FR); ANAP00517, Not Applicable (1011-9000-000); ANAP00518, Not Applicable (1011-9000-000); ANAP00519, Not Applicable (1011-9000-000); ANAM01291, Not Applicable (1011-9000-000); ANAM01292, Not Applicable (1011-9000-000); ANAM01293, Not Applicable (1011-9000-000); ANAN00430, Not Applicable (1011-9000-000); ANAN00431, Not Applicable (1011-9000-000); ANAN00432, Not Applicable (1011-9000-000); ANAN00436, Not Applicable (1011-9000-000); ANAN00437, Not Applicable (1011-9000-000); ANAP00300, Not Applicable (1011-9000-000); ANAQ00766, Not Applicable (1011-9000-000); ANAS00753, Not Applicable (1011-9000-000); ANAP00492, Not Applicable (1011-9000-000); ANAP00493, Not Applicable (1011-9000-000); ANAM00628, Not Applicable (1011-9000-000); ANAL01029, Not Applicable (1011-9000-000); 5479515-1, Not Applicable (2097674-JA); 5479515-2, Not Applicable (2097674-JA); 5479515-3, Not Applicable (2097674-JA); 5479515-4, Not Applicable (2097674-JA); 5479515-5, Not Applicable (2097674-JA); 5479515-6, Not Applicable (2097674-JA); 5479515-7, Not Applicable (2097674-JA); 5479515-8, Not Applicable (2097674-JA); 5479515-9, Not Applicable (2097674-JA); 5480673-1, Not Applicable (2097674-JA); 5480673-2, Not Applicable (2097674-JA); 5480673-3, Not Applicable (2097674-JA); 5480673-4, Not Applicable (2097674-JA); 5480673-5, Not Applicable (2097674-JA); 5480673-6, Not Applicable (2097674-JA); 5480673-7, Not Applicable (2097674-JA); 5480673-8, Not Applicable (2097674-JA); 5483069-1, Not Applicable (2097674-JA); ANAQ01435, Not Applicable (1011-9000-000); ANAM01312, Not Applicable (1011-9000-000); ANAM01313, Not Applicable (1011-9000-000); ANAM01315, Not Applicable (1011-9000-000); ANAM01317, Not Applicable (1011-9000-000); ANAM01318, Not Applicable (1011-9000-000); ANAM01320, Not Applicable (1011-9000-000); ANAM01324, Not Applicable (1011-9000-000); ANAM01325, Not Applicable (1011-9000-000); ANAL01313, Not Applicable (1011-9000-000); ANAL01314, Not Applicable (1011-9000-000); ANAL01315, Not Applicable (1011-9000-000); ANAL01316, Not Applicable (1011-9000-000); ANAL01317, Not Applicable (1011-9000-000); ANAL01318, Not Applicable (1011-9000-000); ANAL01319, Not Applicable (1011-9000-000); ANAL01320, Not Applicable (1011-9000-000); ANAM01302, Not Applicable (1011-9000-000); ANAM01304, Not Applicable (1011-9000-000); ANAN00487, Not Applicable (1011-9000-000); ANAN00488, Not Applicable (1011-9000-000); ANAN00489, Not Applicable (1011-9000-000); ANAN00490, Not Applicable (1011-9000-000); ANAN00491, Not Applicable (1011-9000-000); ANAN00492, Not Applicable (1011-9000-000); ANAR05143, Not Applicable (1011-9000-000); ANAR05144, Not Applicable (1011-9000-000); 5450447-2, Not Applicable (2097674-NL); 5450447-4, Not Applicable (2097674-NL); 5454351-1, Not Applicable (2097674-NL); 5454351-2, Not Applicable (2097674-NL); ANAR00198, Not Applicable (1011-9000-000); ANAR00199, Not Applicable (1011-9000-000); ANAR00200, Not Applicable (1011-9000-000); ANAR00279, Not Applicable (1011-9000-000); ANAM01311, Not Applicable (1011-9000-000); ANAM01314, Not Applicable (1011-9000-000); ANAM01316, Not Applicable (1011-9000-000); ANAM01319, Not Applicable (1011-9000-000); ANAM01321, Not Applicable (1011-9000-000); ANAM01322, Not Applicable (1011-9000-000); ANAM01323, Not Applicable (1011-9000-000); 5456012-1, Not Applicable (2097674-001); 5456012-2, Not Applicable (2097674-001); 5456012-3, Not Applicable (2097674-001); 5456719-1, Not Applicable (2097674-001); ANAN01065, Not Applicable (1011-9000-000); ANAN01066, Not Applicable (1011-9000-000); 5476468-1, Not Applicable (2097674-001); 5476468-10, Not Applicable (2097674-001); 5476468-11, Not Applicable (2097674-001); 5476468-12, Not Applicable (2097674-001); 5476468-13, Not Applicable (2097674-001); 5476468-14, Not Applicable (2097674-001); 5476468-15, Not Applicable (2097674-001); 5476468-16, Not Applicable (2097674-001); 5476468-17, Not Applicable (2097674-001); 5476468-2, Not Applicable (2097674-001); 5476468-3, Not Applicable (2097674-001); 5476468-4, Not Applicable (2097674-001); 5476468-5, Not Applicable (2097674-001); 5476468-6, Not Applicable (2097674-001); 5476468-7, Not Applicable (2097674-001); 5476468-8, Not Applicable (2097674-001); 5476468-9, Not Applicable (2097674-001); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097674-001-US, Not Applicable, (APWV01271); 2097674-001-US, Not Applicable, (APWU01812); 2097674-001-US, Not Applicable, (ANAR00714); 2097674-001-US, Not Applicable, (ANAR00741); 2097674-001-US, Not Applicable, (ANAS00330); 2097674-001-US, Not Applicable, (ANAS01319); 2097674-001-US, Not Applicable, (ANAS01320); 2097674-001-US, Not Applicable, (APWU00486); 2097674-001-US, Not Applicable, (APWU00487); 2097674-001-US, Not Applicable, (APWU00575); 2097674-001-US, Not Applicable, (APWU01267); 2097674-001-US, Not Applicable, (APWX00154); 2097674-001-US, Not Applicable, (APWX00155); 2097674-001-US, Not Applicable, (APWX00156); 2097674-001-US, Not Applicable, (APWX00157); 1011-9000-000, Not Applicable, (ANAS00456); 2097674-001-US, Not Applicable, (ANAM00764); 2097674-001-US, Not Applicable, (ANAM00765); 2097674-001-US, Not Applicable, (ANAM00766); 2097674-001-US, Not Applicable, (ANAM00767); 2097674-001-US, Not Applicable, (ANAM00768); 2097674-001-US, Not Applicable, (ANAM00769); 2097674-001-US, Not Applicable, (ANAM00770); 2097674-001-US, Not Applicable, (ANAM00771); 2097674-001-US, Not Applicable, (ANAM00772); 2097674-001-US, Not Applicable, (ANAM00773); 2097674-001-US, Not Applicable, (ANAM00774); 2097674-001-US, Not Applicable, (ANAM00775); 2097674-001-US, Not Applicable, (APWV00946); 2097674-001, Not Applicable, (ANAL00264); 2097674-001, Not Applicable, (ANAL00265); 2097674-001, Not Applicable, (ANAL00266); 2097674-001, Not Applicable, (ANAK00415); 2097674-001, Not Applicable, (ANAK00703); 2097674-001, Not Applicable, (ANAK00705); 2097674-001, Not Applicable, (ANAK00707); 2097674-001, Not Applicable, (ANAK00709); 2097674-001, Not Applicable, (ANAK00410); 2097674-001, Not Applicable, (ANAK00411); 2097674-001, Not Applicable, (ANAK00413); 2097674-001, Not Applicable, (ANAK00414); 2097674-001, Not Applicable, (ANAK00416); 2097674-001, Not Applicable, (ANAK00417); 2097674-001, Not Applicable, (ANAK00421); 2097674-001, Not Applicable, (ANAL00893); 2097674-001, Not Applicable, (APWU02246); 2097674-001, Not Applicable, (APWV00404); 2097674-001, Not Applicable, (ANAK00412); 2097674-001, Not Applicable, (ANAK00418); 2097674-001, Not Applicable, (ANAK00419); 2097674-001, Not Applicable, (ANAK00420); 2097674-001, Not Applicable, (ANAK00704); 2097674-001, Not Applicable, (ANAK00706); 2097674-001, Not Applicable, (ANAK00708); 2097674-001, Not Applicable, (APWW00334); 1011-9000-000, Not Applicable, (ANAR05371); 2097674-DE, Not Applicable, (ANAS00870); 1011-9000-000, Not Applicable, (ANAR00333); 1011-9000-000, Not Applicable, (ANAJ00122); 1011-9000-000, Not Applicable, (ANAQ01270); 1011-9000-000, Not Applicable, (ANAQ01271); 1011-9000-000, Not Applicable, (ANAQ01272); 1011-9000-000, Not Applicable, (ANAQ01273); 1011-9000-000, Not Applicable, (ANAQ01274); 1011-9000-000, Not Applicable, (ANAQ01275); 1011-9000-000, Not Applicable, (ANAQ01276); 1011-9000-000, Not Applicable, (ANAQ01277); 1011-9000-000, Not Applicable, (ANAR00187); 1011-9000-000, Not Applicable, (ANAR00188); 1011-9000-000, Not Applicable, (ANAR00189); 1011-9000-000, Not Applicable, (ANAR00190); 1011-9000-000, Not Applicable, (ANAR00191); 1011-9000-000, Not Applicable, (ANAR00192); 1011-9000-000, Not Applicable, (ANAR00334); 1011-9000-000, Not Applicable, (ANAR00701); 1011-9000-000, Not Applicable, (APWU02039); 1011-9000-000, Not Applicable, (APWW01068); 2097674-001, Not Applicable, (ANAQ00825); 1011-9000-000, Not Applicable, (ANAR05370); 2097674-FR, Not Applicable, (ANAN01100); 1011-9000-000, Not Applicable, (ANAT00157); 1011-9000-000, Not Applicable, (ANAT00158); 1011-9000-000, Not Applicable, (ANAT00156); 1011-9000-000, Not Applicable, (ANAR05372);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0411-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0411-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-09
Z-0412-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-09
Z-0413-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-09

Product code BSZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)