Z-1227-2022Class I

Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation...

Name: Z-1227-2022 Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation...
Creator: GE Healthcare, LLC
Published: 2022-04-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-04-18 / Open, Classified

FDA source

GE Healthcare, LLC began a recall of Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and Engstrom PRO Ventilators on 2022-04-18. FDA classified it as Class I and gives the reason as "Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1227-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-04-18
Posted: 2022-06-06
Recalling firm: GE Healthcare
Product: Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and Engstrom PRO Ventilators.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
FDA root cause: Under Investigation by firm
Action: The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter the consignees via mail on 04/18/2022. The letter describes the product, problem and actions to be taken. The customers instructed to take the following actions: 1. You can continue to use the affected ventilators while the ventilator is connected to an AC mains power source that is supported by backup emergency power. 2. If it is absolutely necessary to use the ventilator by relying on the battery (such as during required transport where there are no other options), ensure you follow standard clinical practice of having a readily accessible means of appropriate alternative ventilation (for example a bag-valve system) and personnel with the capability to administer this alternative means at all times. 3. Immediately after receiving this communication, perform the Battery Performance Test as described in Appendix A. Replace the batteries when necessary, before patient use. 4. When not in patient use, it is recommended that the device always remains connected to the AC mains power source to prevent battery discharge and degradation, even when in storage. 5. It is recommended that the Battery Performance Test be completed every three months as described in Appendix A. 6. If the device has been in storage for over three months, perform the Battery Performance Test as described in Appendix A prior to use. 7. The backup batteries must be replaced at a minimum every three years. 8. Complete the attached Medical Device Notification Acknowledgement Response form and send to [email protected] If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 88,379 batteries
Distribution: Worldwide Distribution: US (nationwide) to AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and OUS (internationally) to Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Cote D'Ivoire, Mexico, Uruguay, United Kingdom, United Arab Emirates, Turkey, Thailand, Tanzania, Sweden, Spain, Singapore, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Panama, Omar, Norway, Nigeria, Nicaragua, New Zealand, Netherlands, Malaysia, Latvia, Kuwait, Korea, Kenya, Kazakhstan, Japan, Italy, Ireland, Indonesia, India, Hungary, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic.
Product codes and lots: Field Replacement Unit kits PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) and PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1227-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1226-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-06
Z-1227-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-06

Product code CBK

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)