Philips surgical imaging systems missing warning label and safety spacer
Philips has recalled certain surgical C-arm imaging systems delivered to Puerto Rico because they lack required warning labels and are missing a critical Source-to-Skin Distance Spacer component.
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: FDA Class II medical device recall involving missing critical safety components and inadequate labeling. This constitutes a risk-of-harm product where no injuries have been reported, meeting the rubric criteria for High severity.
Plain-English summary
Philips has identified an issue affecting Integris-Allura, Allura Xper, and Azurion surgical C-arm imaging systems delivered to Puerto Rico. The affected systems lack a required warning label and are missing a Source-to-Skin Distance Spacer (also called a Tube-spacer), a critical safety component.
These surgical C-arm systems are used in hospital operating rooms and imaging suites for image-guided therapy and surgical procedures. The missing warning label and spacer component affect the proper operation and safety of these devices.
Healthcare facilities in Puerto Rico that received these system models are subject to this recall.
The recalled product
- Product
- BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
- Manufacturer
- Philips North America
Distribution
Part of a larger recall action
This product is one of 6 recalled by Philips North America 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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