Agency classClass IIOur severity:High FDA (Devices)·Z-0357-2022·Announced 2021-12-15

Diagnostic X-ray imaging system recalled for incomplete temperature specifications

Philips Veradius Unity diagnostic X-ray systems lack required temperature specifications in instructions, creating burn risk. Affected systems should not be used until updated documentation is received.

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 FDA Class II medical device recall involves missing critical safety specifications in the Instructions for Use. The hazard creates a risk of thermal burns, but no injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Philips North America LLC has recalled 462 units of the Veradius Unity with Software Release 2.1, a mobile diagnostic X-ray imaging and viewing system (Model 718132). The recall affects systems distributed worldwide, including the United States.

The Instructions for Use for this system do not specify the maximum surface temperatures for the X-ray tank (the assembly housing the X-ray tube, beam filter, and cooling oil) and the image intensifier/detector. These specifications are required for safe operation. Without knowing the maximum surface temperatures, users may inadvertently contact hot surfaces and sustain thermal burns.

Healthcare facilities and other users of affected systems should contact Philips North America LLC for updated instructions that include the required temperature specifications. Do not operate the system until complete safety documentation has been received and reviewed. Affected units can be identified by their serial numbers, which are listed in the recall notice.

The recalled product

Product: Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic X-ray System
Hazard: burn-injury
incomplete-documentation
Affected units: 462

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Philips North America Llc 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 3 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · burn injury