Agency classClass IIOur severity:High FDA (Devices)·Z-2484-2021·Announced 2021-09-29

Philips Affiniti Ultrasound Systems Recalled for Software Lock-Up During Exams

Philips Ultrasound is recalling Affiniti diagnostic ultrasound systems due to a software defect that intermittently causes device lock-ups when exiting Review Mode during patient exams. No illnesses or injuries have been reported.

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 a risk-of-harm medical device recall involving a software defect that creates functional hazards (intermittent system lock-up during operation) with potential to disrupt patient care. No hospitalizations, serious injuries, or illnesses have been reported, placing this at the High severity level per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Ultrasound Inc is recalling Affiniti Diagnostic Ultrasound Systems, models 30, 50, and 70 with software versions 5.0, 5.0.1, and 5.0.2. Approximately 10,583 systems are affected worldwide, including units distributed throughout the United States and numerous countries globally.

The recalled systems contain a software defect that can intermittently cause the device to lock up and become unresponsive when exiting Review Mode while performing a patient exam. This malfunction could prevent the ultrasound system from functioning properly and disrupt patient care.

The recalled systems have been distributed worldwide and throughout U.S. states and territories. Facilities that have these systems in use should contact Philips Ultrasound Inc for instructions on obtaining a software update to resolve the defect.

No illnesses or injuries related to this defect have been reported to Philips Ultrasound Inc or the FDA at this time.

The recalled product

Product: 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
Manufacturer: Philips Ultrasound Inc
Category: Medical Device — Diagnostic Ultrasound
Hazard: software-defect
system-lockup
device-malfunction
Affected units: 10,583

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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.

See all 2 products in this recall →

Same manufacturer · Philips Ultrasound Inc

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Same hazard · software defect