Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Reported: November 15, 2023 Initiated: October 9, 2023 #Z-0284-2024
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.
Details
- Recalling Firm
- Philips Ultrasound, Inc.
- Units Affected
- 7 systems
- Distribution
- US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
- Location
- Bothell, WA
Frequently Asked Questions
What product was recalled? ▼
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210. Recalled by Philips Ultrasound, Inc.. Units affected: 7 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0284-2024.
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