Z-1137-2008

MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems...

Name: Z-1137-2008 MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2007-11-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-11-29 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021 on 2007-11-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1137-2008
Status: Terminated
Initiated: 2007-11-29
Posted: 2008-05-28
Terminated: 2010-09-17
Recalling firm: Philips North America LLC
Product: MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: Sysco Software Version 2, release 4.1.1

Product code JAA

K050151Class IIMultidiagnost ElevaPhilips Medical Systems North America, Inc. / cleared 2005-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)