Reported Oct 13, 2021 · Terminated
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Philips Ultrasound Inc.
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: Philips Ultrasound Inc · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
- Lot codes and dates
- Affected Serial Numbers/UDI numbers
USD1410130 /N/AUS12110905 /(01)00884838097971(21)US12110905US12110906 /(01)00884838097971(21)US12110906US12111049 /(01)00884838097971(21)US12111049US31310191 /N/AUS31511242 /N/AUS32111072 /(01)00884838097971(21)US32111072US41210049 /N/AUS42111774 /(01)00884838097971(21)US42111774US51210186 /N/AUS62011642 /(01)00884838028098(21)US62011642US71810505 /(01)00884838028098(21)US71810505US72011713 /(01)00884838028098(21)US72011713US72011714 /(01)00884838028098(21)US72011714US82010111 /(01)00884838028098(21)US82010111US91410757 /N/AUS92010327 /(01)00884838028098(21)US92010327US92010512 /(01)00884838028098(21)US92010512USD2011313 /(01)00884838097971(21)USD2011313USD2011314 /(01)00884838097971(21)USD2011314USD2011362 /(01)00884838097971(21)USD2011362USD2011363 /(01)00884838097971(21)USD2011363USD2011480 /(01)00884838097971(21)USD2011480USD2011481 /(01)00884838097971(21)USD2011481USD2011482 /(01)00884838097971(21)USD2011482USD2011483 /(01)00884838097971(21)USD2011483USD2011578 /(01)00884838097971(21)USD2011578USD2011622 /(01)00884838097971(21)USD2011622USD2011623 /(01)00884838097971(21)USD2011623USN1510828 /N/AUSN2011691 /(01)00884838097971(21)USN2011691USO1210225 /N/AUSO2011257 /(01)00884838097971(21)USO2011257USO2012052/ (01)00884838097971(21)USO2012052
- Affected Serial Numbers/UDI numbers
- Amount recalled
- 34 units
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
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
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.
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