Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0 Recalled by Philips Ultrasound Inc Due to Due to a software defect that can intermittently...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Ultrasound Inc directly.
Affected Products
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
Quantity: Total = 10,583 systems (EPIQ and Afiniti)
Why Was This Recalled?
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Ultrasound Inc
Philips Ultrasound Inc has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report