Agency classClass IIOur severity:High FDA (Devices)·Z-0355-2022·Announced 2021-12-15

Philips BV Endura diagnostic X-ray system missing temperature specifications

Philips BV Endura diagnostic X-ray systems lack specifications for maximum surface temperatures in their instructions, creating potential for burn injuries.

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: The product is classified as FDA Class II and presents a risk-of-harm scenario where thermal burn injuries have not yet been reported. The missing maximum temperature specifications in the Instructions for Use represent a critical safety information gap for medical equipment that operates at high temperatures.

Plain-English summary

Philips is recalling the BV Endura diagnostic X-ray system (Model 718075) due to missing safety information in its Instructions for Use. The documentation does not specify the maximum surface temperatures of the X-ray tank (which houses the X-ray tube, beam filter, and cooling oil) or the image intensifier/detector. Without these specifications, operators may face burn injury risk from unidentified hot surfaces.

The recall affects 22 units in the United States. The affected devices were distributed worldwide to numerous countries.

Healthcare facilities and operators using these systems should take precautions to avoid contact with potentially hot components. Facilities should contact Philips for updated instructions or clarification on safe operating procedures and thermal hazards of the equipment.

The recalled product

Product: BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Radiological Equipment
Hazard: burn-injury
thermal-hazard
Affected units: 22

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