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Recall Observatory FDA recall evidence

Device product

BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161

Z-0931-2024

December 15, 2023

Class I

Product summary

Firm
Philips North America
Event
Event 93767
Status
Ongoing
Classification
Class I
Quantity
106 US; 241 OUS
Official record key
device-enforcement:Z-0931-2024

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.