Recall Z-0677-2024 ยท KPS System, Tomography, Computed, Emission
Philips North America
BrightView, Gamma Camera System, Product Code 882480.
| Date | Jan 5, 2024 (initiated Nov 30, 2023) |
| Status | Open, Classified |
| Reason | While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion. |
| Root cause | Device Design |
| Action | On November 30, 2023, the firm notified customers of the issue through Urgent Medical Device Correction Letters. Users were instructed to monitor the patient during system movement when Pre-Programed Motion is in use and review the warning and caution guidance information provided with the recall notice, and which is also outlined in the Instructions for Use. Philips will contact you to schedule a time for a field service engineer to visit your site and install a technical solution to resolve this issue. If you need any further information or support concerning this issue, please contact yo |
| Quantity | 359 US; 328 OUS |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062298 | APOLLO GAMMA CAMERA SYSTEM Adac Laboratories, Aug 23, 2006 |