Recall Z-0988-2012 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs.
| Date | Feb 10, 2012 (initiated Nov 18, 2011) |
| Status | Terminated |
| Reason | Philips was informed that the detector buckets may experience weakness over time. As a result, this could cause the detector bucket to separate from the mounting plate of the gantry and eventually result in the detector falling. |
| Root cause | Nonconforming Material/Component |
| Action | On 11/15/2011 Philips sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected product, the problem, the hazard involved, and the actions to be taken by users and the Philips. Customers are to place the letter in their User Documentation. Philips service will arrange a time to inspect customers' systems and conduct the appropriate field safety correction. Customers are to contact their local Philips representative if they need further support or information. In the US and Canada, customers can contact Philips Healthcare Customer Care Solution |
| Quantity | 795 units |
| Distribution | Worldwide Distribution -- USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PRO, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and the territory of Puerto Rico; and countries |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964712 | PRISM XPVT SYSTEM (210823) Philips Medical Systems (Cleveland), Inc., Feb 21, 1997 |