Reported Apr 19, 2017 · Terminated
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
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?
Vivid E95/E90/E80H45581DCH45581LB and H45581DA
- Lot codes and dates
- Mfg. Lot or Serial # System ID 1DEMO__US75
938 of 938 codes
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
1,002 of 1,002 codes
AU00416GEDEM2US34AU00908RO4547US05AU50175RO4766US04AU00276PPR35413AU00850PER18316AU00904PER06648AU01049PER06649AU01068PES05822AU01209PER19023AU50065PER03525AU50171PPR23107AU50387PPR40828AU00583600043US06AU00656PL1023US25AU50285PL4430US20AU50310PL4176US01AU503771557UL0337AU01037NO4031US23AU01060NO4014US59AU01143NO4088US63AU50130NO4043US23AU50236NO4064US21AU50247NO4064US22AU50353NO4068US92AU0036585140386500AU0064285142791102AU0106685150626441AU01230NC1071US01AU00971LDD0449AU01051STK01402
- Mfg. Lot or Serial # System ID 1
- Amount recalled
- 971(412 US; 559 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.
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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