Philips North America Recall 93767
Description: 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
Philips North America Recall 93767 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0929-2024 |
| Event ID | 93767 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. International distribution worldwide. |
| Quantity | 302 US; 264 OUS |
| Recall 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. |
| Device Classification | 20240214 |
| Device Code Info | All serial numbers are affected. No UDI-DI available for this product. |
| Center Classification Date | 20240202 |
| Recall Initiation Date | 20231215 |
| Recalling Firm | Philips North America |
| Initial Notification | Letter |
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