BrightView X Gamma Camera Detector May Fall, Causing Patient Injury
Detectors in Philips BrightView X gamma cameras may fall unexpectedly due to component failure, risking patient injury including fractures and lacerations.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This product is classified as FDA Class I, which requires a minimum severity score of 4. The recall addresses a structural failure that creates potential for serious patient injury including fractures and lacerations.
Plain-English summary
Philips North America is recalling BrightView X gamma cameras due to a detector component that may unexpectedly fall as a result of component failure.
All serial numbers of the BrightView X gamma camera are affected by this recall. Approximately 56 units were distributed in the United States and 46 units internationally.
When the detector is positioned below the center of the gantry, there is a potential for abrasion, contusion, laceration, and fracture to the patient's lower limbs, as well as interruption to normal system operation. When positioned above the center of the gantry, there may be an interruption to normal system operation.
The recalled product
- Product
- BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
- 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)
- All serial numbers are affected. No UDI-DI available for this product.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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