Recall Z-1892-2009 ยท KPS System, Tomography, Computed, Emission
Phillips Nuclear Medicine
BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480 Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the
| Date | Sep 16, 2009 (initiated Jul 2, 2009) |
| Status | Terminated |
| Reason | Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit. |
| Root cause | Process control |
| Action | Firm initiated its recall notification on July 6, 2009 issuing a field safety notice to its consignees via FedEx and internationally through its personnel. Responses will be tracked for effectiveness. Questions may be directed to Philips Customer Care Center at 1.800.722.9377. |
| Quantity | 288 units |
| 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 |