Z-0071-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- August 19, 2021
- Termination Date
- September 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
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.
Code Information
Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US92010594