Philips Affiniti 70 recall: Software Issue
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Why was Philips Affiniti 70 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292
- Product
- Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
- Recalling firm
- Philips Ultrasound, Inc.
- Quantity
- 7 systems
- Distribution
- US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)