Recall Z-0261-2010 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640
| Date | Nov 13, 2009 (initiated Jan 26, 2009) |
| Status | Terminated |
| Reason | Upper patient pallet component of the recalling firm's Gemini PET/CT system may be thinner than normally required which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight. |
| Root cause | Process change control |
| Action | The firm notified customers with an "URGENT - Field Safety Notice" which was sent to the user/customers via FedEx on 1/26/2009. The letter informs customers of this potential safety hazard; the actions to be taken by the user/customer in order to mitigate risk to patients while undergoing scans; and the actions planned by Philips Medical's Service Engineers in order to correct the problem. The notification refers the user/customers to the applicable sections of their Systems Operations and Systems Information Manuals for a review on procedures for safely loading; unloading; and monitoring p |
| Quantity | 9 units |
| Distribution | The recalled products were distributed to customers in the following states within the U. S.: OH, GA, MI, and CA and to customers overseas in: Germany, France Japan, and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052640 | GEMINI RAPTOR Philips Medical Systems (Cleveland), Inc., Oct 7, 2005 |