BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
Reported: February 14, 2024 Initiated: December 15, 2023 #Z-0931-2024
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.
Details
- Recalling Firm
- Philips North America
- Units Affected
- 106 US; 241 OUS
- Distribution
- Domestic distribution nationwide. International distribution worldwide.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161. Recalled by Philips North America. Units affected: 106 US; 241 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-0931-2024.
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