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Recall Observatory FDA recall evidence

Device product

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

Z-1227-2022

April 18, 2022

Class I

Product summary

Firm
GE Healthcare, LLC
Event
Event 90076
Status
Ongoing
Classification
Class I
Quantity
88,379 batteries
Official record key
device-enforcement:Z-1227-2022

Official wording

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

Code information: 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).

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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