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Recall Observatory FDA recall evidence

Device product

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

Z-0929-2024

December 15, 2023

Class I

Product summary

Firm
Philips North America
Event
Event 93767
Status
Ongoing
Classification
Class I
Quantity
302 US; 264 OUS
Official record key
device-enforcement:Z-0929-2024

Official wording

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 information: All serial numbers are affected. No UDI-DI available for this product.

Distribution pattern: Domestic distribution nationwide. International distribution worldwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.