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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 7
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Ultrasound, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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