FDA Enforcement
Class I
Ongoing
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
Recall: Z-0929-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0929-2024
- 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, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
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
302 US; 264 OUS