Recall Z-1137-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems North America Co. Phillips
MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021
| Date | May 28, 2008 (initiated Nov 29, 2007) |
| Status | Terminated |
| Reason | Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. The loss of system availability could occur during an interventional |
| Root cause | Software design |
| Action | On 11/29/07 Philips Medical Systems sent a letter dated 11/28/07 to customers stating that if users perform certain image file housekeeping operations, fluoroscopy cannot be performed and new exposures cannot be acquired until those operations are complete. It also instructs that the unavailability of fluoroscopy and exposure can be avoided by not pressing the "Delete All Images" button until any pending Autopush operation is complete. FCO 70800067 will be issued to service representatives to install new software. |
| Quantity | 9 units were distributed to hospitals in the US, 6 were installed, 3 were not installed or in use. |
| Distribution | USA Distribution - CO, MN, NC, NJ and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050151 | MULTIDIAGNOST ELEVA Philips Medical Systems North America, Inc., Feb 9, 2005 |