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Recall Observatory FDA recall evidence

Device product

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

Z-0071-2022

August 19, 2021

Class II

Product summary

Firm
Philips Ultrasound Inc
Event
Event 88625
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0071-2022

Official wording

Reason: 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.

Code information: Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US92010594

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CA, MA, MD, MI, MS, NC, NY, OH, VA, WA and the countries of Australia, Portugal, Netherlands, Canada, Netherlands, Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.