MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98
FDA device recall Z-1137-2008 · posted 2008-05-28 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 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.
- Date initiated
- 2007-11-29
- Date posted
- 2008-05-28
- Date terminated
- 2010-09-17
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIDIAGNOST ELEVA (K050151) | Philips Medical Systems North America, Inc. | 2005-02-09 |