PlainRecalls
FDA Devices Critical 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

Reported: February 14, 2024 Initiated: December 15, 2023 #Z-0929-2024

Product 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 for Recall

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.

Details

Recalling Firm
Philips North America
Units Affected
302 US; 264 OUS
Distribution
Domestic distribution nationwide. International distribution worldwide.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Philips North America. Units affected: 302 US; 264 OUS.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 14, 2024. Severity: Critical. Recall number: Z-0929-2024.