Reported Oct 16, 2019 · Terminated
AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- AIR Technology Anterior Array
- Catalogue Numbers(a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems
- Lot codes and dates
- Catalogue # UDI # Mfg. Lot or Serial #
66 of 66 codes
5746694010084068213861111181213210033933957466940100840682138611111809122100324324574669401008406821386111118053121003113115746694010084068213861111190102210034034057466940100840682138611111811302100334334574669401008406821386111118083021003233235746694010084068213861111180913210032532557466940100840682138611111809192100326326574669401008406821386111118012921003033035746694010084068213861111180123210030130157466940100840682138611111808152100319319574669401008406821386111118082721003203205746694010084068213861111181204210033533557466940100840682138611111806072100313313574669401008406821386111118071821003153155746694010084068213861111180212210030730757466940100840682138611111811092100328328574669401008406821386111118120721003373375746694010084068213861111180723210031631657466950100840682138611111808282100321321
- Catalogue # UDI # Mfg. Lot or Serial #
- Amount recalled
- 22 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
Why it was recalled
The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected.
This product could cause temporary or reversible health problems — stop using it.
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.