Recall Z-0071-2022— Philips Ultrasound Inc

Name: FDA recall Z-0071-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-19

Class II · Terminated

Class II FDA medical device recall by Philips Ultrasound Inc, initiated 2021-08-19, terminated 2024-09-06. It names one FDA 510(k) clearance: K201012. Product: Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,. 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..

Recalling firm: Philips Ultrasound Inc
Classification: Class II
Status: Terminated
Initiated: 2021-08-19
Terminated: 2024-09-06
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K201012 — EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.·cleared 2020-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.