Philips Affiniti 70 Ultrasound System Software Defect May Cause Delayed Images
Philips is recalling 7 Affiniti 70 diagnostic ultrasound systems with software version 10.0 due to a defect that may produce delayed imaging instead of real-time images.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with a functional defect that creates risk of diagnostic error. No illnesses or injuries have been reported, meeting the rubric criterion for High severity: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Ultrasound, Inc. is recalling 7 Affiniti 70 diagnostic ultrasound systems (Model # 795210) that may present a delayed image instead of a real-time image. The defect affects systems operating with software version 10.0.
The affected devices were distributed across multiple US states (Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Montana, Nebraska, Nevada, Ohio, Tennessee, Texas, Utah, Virginia) and Canada. The specific systems are identified by the following serial numbers: US523F1930, US918F1158, US918F1159, US723F1377, US523F1496, US523F1497, and US217F0292.
Delayed imaging may compromise diagnostic accuracy and impact clinical decision-making. Healthcare providers using affected systems should verify their software version and contact Philips Ultrasound, Inc. to obtain software updates.
The recalled product
- Product
- Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
- Manufacturer
- Philips Ultrasound, Inc.
- Hazard
- delayed-imaging
Distribution
Distributed in 17 states:
- AZ
- CA
- CT
- FL
- GA
- ID
- IL
- KY
- MD
- MT
- NE
- NV
- OH
- TN
- TX
- UT
- VA
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