Z-0284-2024 Class II
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- October 9, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 systems
Product Description
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Reason for Recall
Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
Distribution Pattern
US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
Code Information
Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292