GE Healthcare, LLC recalls Replacement back up batteries distributed on or after April
Recalled Product
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
Hazard / Issue
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 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).
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