Recall Z-0250-2012 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems
SKYLight Gamma Camera System; SKYLIGHT, 5/8",SPECT; Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
| Date | Nov 19, 2011 (initiated Sep 27, 2011) |
| Status | Terminated |
| Reason | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Root cause | Device Design |
| Action | Philips Medical Systems sent a "Customer Information" letter dated September 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter lists additional precautions the customers should use while operating the device. Philips will notify customers for replacing the affected product through an Action for Performance-Proactive Field Change Order to resolve the issue. Contact Philips Customer Care Solutions at 1-800-722-9377, option 5, for questions concerning this notice. |
| Quantity | 658 - all units in recall |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000908 | SKYLIGHT IMAGING SYSTEM Adac Laboratories, Apr 5, 2000 |