medical Class II Updated 2021-10-13

Philips Ultrasound Inc recalls Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System

Recalled Product

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Affected Serial Numbers/UDI numbers: USD1410130 /N/A, US12110905 /(01)00884838097971(21)US12110905, US12110906 /(01)00884838097971(21)US12110906, US12111049 /(01)00884838097971(21)US12111049, US31310191 /N/A, US31511242 /N/A, US32111072 /(01)00884838097971(21)US32111072, US41210049 /N/A, US42111774 /(01)00884838097971(21)US42111774, US51210186 /N/A, US62011642 /(01)00884838028098(21)US62011642, US71810505 /(01)00884838028098(21)US71810505, US72011713 /(01)00884838028098(21)US72011713, US72011714 /(01)00884838028098(21)US72011714, US82010111 /(01)00884838028098(21)US82010111, US91410757 /N/A, US92010327 /(01)00884838028098(21)US92010327, US92010512 /(01)00884838028098(21)US92010512, USD2011313 /(01)00884838097971(21)USD2011313, USD2011314 /(01)00884838097971(21)USD2011314, USD2011362 /(01)00884838097971(21)USD2011362, USD2011363 /(01)00884838097971(21)USD2011363, USD2011480 /(01)00884838097971(21)USD2011480, USD2011481 /(01)00884838097971(21)USD2011481, USD2011482 /(01)00884838097971(21)USD2011482, USD2011483 /(01)00884838097971(21)USD2011483, USD2011578 /(01)00884838097971(21)USD2011578, USD2011622 /(01)00884838097971(21)USD2011622, USD2011623 /(01)00884838097971(21)USD2011623, USN1510828 /N/A, USN2011691 /(01)00884838097971(21)USN2011691, USO1210225 /N/A, USO2011257 /(01)00884838097971(21)USO2011257, USO2012052/ (01)00884838097971(21)USO2012052
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