Recall Z-2496-2018 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)900010 (01)00884838059559(21)900011 (01)00884838059559(21)900012 (01)00884838059559(21)900013 (01)00884838059559(21)900014 (01)0088
| Date | May 21, 2018 |
| Status | Terminated |
| Reason | The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet. |
| Root cause | Software design |
| Action | On May 21, 2018, Philips issued Customer Information notices to their clients. A Philips Field Service Engineer will contact customers directly to schedule the updates at your specific site. If you need any further information or support concerning this issue, please contact your local Philips representative. For SUPPORT in North America and Canada, contact the Customer Care Solutions Center 1-800-722-9377, follow prompts. |
| Quantity | 32 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA, GA, LA, MD, MI, NY, OH, TN, TX, VT, Washington DC & WI Internationally - Canada, Mexico, Belgium, France, Israel, Luxembourg, Netherlands, Singapore, Spain & Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123599 | INGENUITY DIGITAL PET/CT Philips Healthcare (Cleveland), Jul 12, 2013 |