BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format...
FDA Recall #Z-0931-2024 — Class I — December 15, 2023
Product Description
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
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.
Recalling Firm
Philips North America — Cambridge, MA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
106 US; 241 OUS
Distribution
Domestic distribution nationwide. International distribution worldwide.
Code Information
All serial numbers are affected. No UDI-DI available for this product.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated