Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0071-2022 — Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

U.S. FDA — Device Enforcement · United States · 2021-08-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0071-2022
Date of alert
2021-08-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Ultrasound Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838098015
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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