Reported Jun 15, 2022 · Ongoing
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and…
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
- Lot codes and dates
- Field Replacement Unit kits PN1009-5682-000-S (BTRY SEALED
- LEAD ACID RECHARGEABLE 12V) and PN5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR)
- Amount recalled
- 88,379 batteries
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Stop using this product now
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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