—#66580

Product

MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, Bothell, WA, 98021

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K050151
Affected lot / code info: Sysco Software Version 2, release 4.1.1

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: USA Distribution - CO, MN, NC, NJ and TX.

Timeline

Recall initiated: 2007-11-29
Posted by FDA: 2008-05-28
Terminated: 2010-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66580. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.