Reported Jan 29, 2020 · Terminated
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia 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?
- Carestation 620/650/650c
- A2 Product Usageanesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult
- Lot codes and dates
- CARESTATION 620 A2, Model number 1012-9620-002, No UDI, OUS only Mfg. Lot or Serial #CARESTATION 650 A2, Model Number 1012-9650-002, No UDI, OUS only Mfg. Lot or Serial #
211 of 211 codes
SM618370003WASM618370004WASM618370005WASM618370006WASM618370010WASM618370070WASM618370071WASM618380001WASM618380002WASM618380008WASM618380009WASM618380010WASM618380011WASM618450033WASM618480061WASM618500014WASM619110035WASM618360022WASM618360027WASM618360028WASM618370020WASM618370021WASM618370022WASM618370023WASM618370051WASM618370052WASM618370053WASM618370056WASM618360007WASM619030013WASM619030014WASM619030015WASM619030016WASM619040001WASM619150001WASM618430007WASM618440004WASM618480064WASM618390031WASM619100010WASM618420021WASM618420022WASM618420023WASM618420024WASM618480063WASM619070003WASM619170051WASM618460048WASM619070001WASM619070002WASM618410001WASM618410002WASM618500015WASM618450034WASM618380007WASM619030007WASM619110044WASM619120001WASM619135003WASM618440035WA
CARESTATION 650C A2, Model Number 1012-9655-002, No UDI, OUS only Mfg. Lot or Serial # SM818370001WA SM818480001WA SM818480005WA66 of 66 codes
SM718450028WASM718450029WASM718450030WASM718450031WASM718450032WASM718450033WASM718340013WASM718340014WASM718340015WASM718340019WASM718340020WASM718370012WASM718410018WASM718510028WASM718510029WASM718490037WASM718380010WASM718380011WASM718380006WASM718380004WASM718490029WASM718490030WASM718490032WASM718490033WASM718490034WASM718490035WASM718340018WASM718360037WASM718360038WASM718360042WASM718360043WASM718470055WASM718490024WASM718490025WASM718490026WASM718490027WASM718490028WASM718370013WASM719070010WASM719070011WASM719070012WASM719070013WASM719070014WASM719070015WASM718380002WASM718380003WASM719230023WASM719230024WASM719230025WASM718490036WASM718370074WASM718370075WASM719240003WASM718370031WASM718370032WASM718370033WASM718370073WASM718470056WASM718510030WASM719110001WA
- CARESTATION 620 A2, Model number 1012-9620-002, No UDI, OUS only Mfg. Lot or Serial #
- Amount recalled
- 280 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
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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