PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 13, 2021 Initiated: August 19, 2021 #Z-0071-2022

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.

Details

Recalling Firm
Philips Ultrasound Inc
Units Affected
1 unit
Distribution
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.
Location
Bothell, WA

Frequently Asked Questions

What product was recalled?
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,. Recalled by Philips Ultrasound Inc. Units affected: 1 unit.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0071-2022.