Recall Z-0398-2011 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems
SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Systems (Cleveland), Cleveland OH. Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medi
| Date | Nov 17, 2010 (initiated Oct 15, 2010) |
| Status | Terminated |
| Reason | Detector arm assembly may slide to hardware limit, potentially causing impact. |
| Root cause | Component change control |
| Action | Firm will notify consignees via Urgent - Medical Device Correction, dated Nov 3, 2010, via FedEx. The letter identified the affected product, described the problem, the hazard involved, how to identify affected products, actions to be taken, and actions planned by Philips. Customers are to contact their Field Safety Engineer immediately to schedule an inspection of their system. If customers suspect that the identified problem has occurred with their device, they should immediately stop using the system until Philips has confirmed it as safe to use. If customers need further information co |
| Quantity | 24 units |
| Distribution | Worldwide Distribution -- USA and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000908 | SKYLIGHT IMAGING SYSTEM Adac Laboratories, Apr 5, 2000 |