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.
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 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
- Hazard
- burn-injury
- incomplete-documentation
Distribution
Distributed nationwide across the United States.
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