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U.S. Department of Health and Human Services

Class 2 Device Recall Philips MutliDiagnost Eleva FD

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  Class 2 Device Recall Philips MutliDiagnost Eleva FD see related information
Date Initiated by Firm November 29, 2007
Date Posted May 28, 2008
Recall Status1 Terminated 3 on September 17, 2010
Recall Number Z-1137-2008
Recall Event ID 45959
510(K)Number K050151  
Product Classification fluoroscopic x-ray system - Product Code JAA
Product MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems,
Bothell, WA, 98021
Code Information Sysco Software Version 2, release 4.1.1
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Sarah Baxter
425-487-7602
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
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