Medical imaging systems recalled for missing safety spacer and warning label
Philips is recalling Integris-Allura IGTS Fixed Systems delivered to Puerto Rico, Guam, and the Virgin Islands due to missing Source-to-Skin Distance Spacers and required warning labels.
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 a Class II medical device recall involving missing safety-critical components (radiation-distance control spacer and warning label). No illnesses or injuries have been reported. The hazard is theoretical but relates to radiation safety control, warranting a High severity rating.
Plain-English summary
Philips North America is recalling Integris-Allura IGTS Fixed Systems that were delivered to Puerto Rico, Guam, and the Virgin Islands. These medical imaging systems were distributed without required warning labels and are missing the Source-to-Skin Distance Spacer (also known as the Tube-spacer), which is a critical safety component.
The missing spacer and warning label create a safety risk because the spacer is designed to control and maintain the proper distance between the radiation source and the patient's skin during imaging procedures. Without this component, the required safety parameters cannot be ensured during operation.
If you have received one of these systems, contact Philips North America immediately to obtain the missing warning label and Source-to-Skin Distance Spacer. Do not operate the equipment until both the warning label and spacer have been installed.
The recalled product
- Product
- Integris-Allura IGTS Fixed Systems
- Manufacturer
- Philips North America
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- INTEGRIS Allura 15-12 (mono) 68
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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