Reported Jun 15, 2022 · Ongoing
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM…
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?
- Back up batteries
- in Ventilators labeled as the followinga. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
- Lot codes and dates
- a
- Model Number1506-8600-000 and/or 1506-8600-000-XXXXXX
- UDI/DI Number00840682102346
- Serial Numbers
2,954 of 2,954 codes
CBRZ06959CBRZ80171CBRZ80257CBRZ40111CBRZ85239CBRZ05811CBRZ05833CBRZ05850CBRZ05852CBRZ05857CBRA01434CBRA01435CBRA01436CBRZ80137CBRZ80153CBRZ80197CBRZ84891CBRA01744CBRA01745CBRA01746CBRA01747CBRA01748CBRA01751CBRA01756CBRZ85298CBRZ85300CBRZ85305CBRZ85338CBRZ07643CBRZ07668CBRZ07678CBRZ07690CBRZ07691CBRZ81955CBRZ82059CBRZ85119CBRA01503CBRA01506CBRZ03482CBRZ03483CBRZ03492CBRZ03494CBRA01674CBRA01675CBRA01676CBRA01677CBRA01678CBRA01679CBRA01680CBRA01681CBRA01682CBRA01683CBRA01684CBRA01685CBRA01686CBRA01687CBRA01688CBRZ07601CBRZ07612CBRZ07624
- Amount recalled
- 34,940 ventilators
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new GE Healthcare, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.