FDAFDA · Food and drugs·Recall number Z-0931-2024
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
Published February 14, 2024 · Recall initiated: December 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America
- Distributor
- Domestic distribution nationwide. International distribution worldwide.
- Lot
- All serial numbers are affected. No UDI-DI available for this product.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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