FDA Enforcement
Class II
Completed
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Recall: Z-0284-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0284-2024
- Event ID
- 93218
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Philips Ultrasound, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- October 9, 2023
- Classification Date
- November 8, 2023
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431, United States
Description
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Reason
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.
Code Info
Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292
Distribution
US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
Quantity
7 systems