Reported Apr 17, 2013 · Terminated
GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2…
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 Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.
- Lot codes and dates
- Mfg Lot or Serial #
2,061 of 2,061 codes
176132SU9176138SU6178028SU7158247SU7172656SU1187599SU6201614SU5201615SU2195234SU0195237SU3161686SU1203123SU5170272SU9189160SU5189162SU1170273SU7185619SU4176924SU9191894SU5159964SU6159768SU1170197SU8158248SU5171540SU8171541SU6160741SU5160742SU3160743SU1159766SU5197761SU0198949SU0195241SU5189928SU5164268SU5159963SU8185116SU1195242SU3201967SU7166218SU8185968SU5189165SU4189166SU2189167SU0189168SU8189169SU6195235SU7195236SU5171371SU8168779SU7189163SU9190393SU9159767SU3167274SU0201464SU5195233SU2171369SU2177085SU8186501SU3171370SU0187022SU9
- Mfg Lot or Serial #
- Amount recalled
- 2061
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso
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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