Gamma Camera Detector May Fall Due to Component Failure
The detector in Philips BrightView XCT gamma cameras may fall unexpectedly due to component failure. If it falls below the center of the gantry, it could cause abrasion, contusion, laceration, or fracture to patients' lower limbs.
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 is an FDA Class I medical device recall, requiring a minimum severity level of 4. No injuries or deaths have been reported—only potential hazards from component failure—so the recall is rated Severe rather than Critical.
Plain-English summary
The recalled product is the BrightView XCT, a gamma camera used for single-photon emission computed tomography (SPECT) imaging. Manufactured by Philips North America, the device is distributed nationwide in the United States and worldwide internationally.
The detector component may unexpectedly fall due to component failure. When the detector is positioned below the center of the gantry, there is a potential risk of abrasion, contusion, laceration, and/or fracture to patients' lower limbs, in addition to possible interruption of normal system operation. When the detector is positioned above the center of the gantry, there may be an interruption to normal system operation.
Patients and medical facilities using the BrightView XCT should cease use immediately and contact Philips North America for instructions on remediation or replacement. The FDA is overseeing this Class I recall.
The recalled product
- Product
- BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
- 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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