Replacement back up batteries distributed on or after April… recallZ-1227-2022 · GE Healthcare, LLC · initiated Apr 18, 2022

Why it was recalled

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number

Z-1227-2022

Status

Open, Classified

Initiated by the company

Apr 18, 2022

Posted by the FDA

Jun 6, 2022

Recalling firm

GE Healthcare, LLC

Quantity

88,379 batteries

Product code

CBK

FDA submissions

K111116, K142679

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 description

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

Other devices under the same FDA submission

1 device cleared under K111116, K142679 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• CARESCAPE R860

  Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall1 death4,346 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 90076).

• Z-1226-2022 · Open, Classified
  Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)