FDA Enforcement
Class I
Ongoing
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
Recall: Z-0931-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0931-2024
- Event ID
- 93767
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- December 15, 2023
- Classification Date
- February 2, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2296, United States
Description
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
Reason
Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.
Code Info
All serial numbers are affected. No UDI-DI available for this product.
Distribution
Domestic distribution nationwide. International distribution worldwide.
Quantity
106 US; 241 OUS