Reported Apr 30, 2014 · Terminated
GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
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?
- GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
- Lot codes and dates
- Mfg Lot or Serial # System ID
891 of 891 codes
0000000VE90667VE90006670000000VE90680VE90006800000000VE90878VE90008780000000VE91045VE90010450000000VE91821VE90018210000000VE91826VE9R0018260000000VE92470VE9R0024700000000VE93780VE9R0037800000000VE94119VE9R0041190000000VE94120VE9R0041200000000VE94291VE9R0042910000000VE94521VE90045210000000VE94736VE9R0047360000000VE94790VE9R0047900000000VE94876VE9R0048760000000VE95024VE9R0050240000000VE95025VE9R0050250000000VE95027VE9R0050270000000VE95028VE9R0050280000000VE95222VE9R0052220000000VE95226VE9R0052260000000VE95271VE9R0052710000000VE95302VE9R0053020000000VE95319VE9R0053190000000VE95558VE9R0055580000000VE95597VE9R0055970000000VE95599VE9R0055990000000VE95604VE9R005604X0000000VE95654VE90056540000000VE95908VE9005908
- Mfg Lot or Serial # System ID
- Amount recalled
- 447 (81US, 366 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat.
This product could cause temporary or reversible health problems — stop using it.
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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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