Philips BV Pulsera X-ray Systems Missing Required Temperature Documentation
Philips has recalled BV Pulsera mobile X-ray systems due to missing temperature specifications in the instructions for use. The X-ray tank and image intensifier lack maximum surface temperature documentation, creating a burn hazard.
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 addressing a documentation defect where required safety information—maximum surface temperatures—is absent from the Instructions for Use. The thermal burn hazard is explicitly stated in the source. No specific injury counts or hospitalizations are reported. The risk-of-harm scenario combined with the Class II designation and missing required labeling supports a High severity rating.
Plain-English summary
Philips North America LLC has recalled 1,201 units of the BV Pulsera model 718095 mobile diagnostic X-ray system. The system is distributed worldwide. The recall addresses a documentation defect in the product's Instructions for Use.
The Instructions for Use do not specify the maximum surface temperature of the X-ray tank—the assembly containing the X-ray tube, beam filter, and cooling oil—or the image intensifier/detector. These temperature specifications are required safety information. The missing documentation creates a risk of thermal burn injury to users who may contact these hot surfaces during system operation.
The recalled product
- Product
- BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
- Affected units
- 1,201
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.
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