Z-2707-2014Class II

Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms...

Name: Z-2707-2014 Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms...
Creator: Spacelabs Healthcare Inc
Published: 2014-08-26
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-08-26 / Terminated / root cause: manufacturing process

FDA source

Spacelabs Healthcare Inc began a recall of Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393... on 2014-08-26. FDA classified it as Class II and gives the reason as "The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2707-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-26
Posted: 2014-09-25
Terminated: 2015-06-26
Recalling firm: GE Healthcare
Product: Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION (Expanded)" letter dated 5 September 2014 to all consignees in the US. This letter identified recalled model 91367, 91369, 91370, 91387, and 91393, Upgrade Kit 040-1548-00, Equipped with the Perioperative Option (-D), problem, and actions to be taken. On September 12, 2014, a recall notification letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. The notification letter stated that the Operating Room staff may not be aware that alarm tones are off if the device has been left in the END CASE state. If the customers make use of the Perioperative START CASE / END CASE feature, they should advise the clinicians to familiarize themselves with this feature as described in the Perioperative section of the Operations Manual. In particular, they should know how to confirm the state of the alarm tones prior to starting a case. The firm's Field Service Engineers will contact customers to schedule a time to come out to update affected monitors at no cost. Customers have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025.
Quantity in commerce: 82 units distributed in US and 140 units distributed outside US
Distribution: Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argentina, Australia, Canada, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Italy, Netherlands, New Zealand, Panama, Paraguay, Poland, Singapore, Spain, Sri Lanka, Switzerland, Tunisia, United Kingdom, and Uruguay.
Product codes and lots: The same KIT PART Number (PN 040-1458-00) identified on 12 units distributed IN the US and on 3 units distributed OUTSIDE of the US. These 15 units will receive serial numbers after the software upgrade is installed. THERE ARE 70 SERIAL NUMBERS ON UNITS DISTRIBUTED IN THE US: 040-1548-00, 1367-000033, 1369-001517, 1369-003051, 1369-003077, 1369-004247, 1369-005914, 1369-006877, 1369-007165, 1369-008519, 1369-010292, 1369-011637, 1369-017520, 1369-061217, 1370-000013, 1370-000014, 1370-000025, 1370-000095, 1370-000285, 1370-000449, 1370-000471, 1370-000579, 1370-000658, 1370-001700, 1370-002494, 1370-002510, 1370-003785, 1370-004176, 1370-004184, 1370-004275, 1370-004292, 1387-000465, 1387-000535, 1387-000543, 1387-001071, 1387-001677, 1387-006200, 1387-010824, 1387-010830, 1387-011914, 1387-014142, 1387-014159, 1387-014184, 1387-014186, 1387-014187, 1387-014188, 1387-014596, 1387-015721, 1387-015722, 1387-015723, 1387-016045, 1387-018424, 1387-018947, 1387-019766, 1387-019768, 1387-019769, 1387-019771, 1387-019772, 1387-100036, 1387-101646, 1387-104672, 1387-105801, 1387-105811, 1387-105812, 1387-105882, 1393-000442, 1393-000579, 1393-000580, 1393-000581, 1393-000582, and 387-002421. THERE ARE 137 SERIAL NUMBERS IDENTIFIED ON UNITS DISTRIBUTED OUTSIDE OF THE US: 1369-000011, 1369-000165, 1369-000407, 1369-000928, 1369-002976, 1369-003388, 1369-005316, 1369-005334, 1369-006100, 1369-006281, 1369-007338, 1369-009142, 1369-009143, 1369-009144, 1369-009145, 1369-009146, 1369-009889, 1369-009890, 1369-011741, 1369-011742, 1369-011743, 1369-011744, 1369-011745, 1369-013721, 1369-016648, 1369-016649, 1369-017759, 1369-017791, 1369-017792, 1370-000026, 1370-000725, 1370-000771, 1370-002373, 1370-002378, 1370-002380, 1370-002381, 1370-002382, 1370-002383, 1370-002384, 1370-003809, 1370-004133, 1370-004277, 1370-004509, 1370-004510, 1370-004511, 1370-004516, 1370-004617, 1370-200366, 1370-200370, 1370-200374, 1370-200375, 1370-200376, 1370-200378, 1370-200380, 1370-200471, 1370-200473, 1370-200474, 1370-200475, 1370-200476, 1370-200691, 1387-000044, 1387-000447, 1387-000467, 1387-000548, 1387-001086, 1387-002157, 1387-005006, 1387-008003, 1387-008310, 1387-010742, 1387-013241, 1387-013716, 1387-014610, 1387-018104, 1387-018105, 1387-018171, 1387-018176, 1387-018277, 1387-018638, 1387-018817, 1387-019563, 1387-100148, 1387-100150, 1387-100151, 1387-100155, 1387-100906, 1387-101061, 1387-101062, 1387-101063, 1387-101064, 1387-101065, 1387-101066, 1387-101067, 1387-102222, 1387-103550, 1387-103659, 1387-104462, 1387-105831, 1387-105832, 1387-105833, 1387-105834, 1393-000013, 1393-000517, 1393-000518, 1393-000519, 1393-000520, 1393-000521, 1393-000522, 1393-000523, 1393-000524, 1393-000525, 1393-000808, 1393-000809, 1393-000822, 1393-000831, 1393-000833, 1393-000834, 1393-000851, 1393-000852, 1393-00235, 1393-00236, 1393-00237, 1393-00238, 1393-00239, 1393-00240, 1393-00241, 1393-00335, 1393-00346, 1393-00347, 1393-00348, 1393-00349, 1393-00350, 1393-00351, 1393-00352, 1393-00353, 1393-00354, AND 1393-00355.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2707-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2707-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-25

Product code MHX

K102422Class IISpacelabs Medical Patient MonitorsSpacelabs Medical, Inc. / cleared 2010-12-07

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)