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U.S. Department of Health and Human Services

Class 2 Device Recall Phillips Endura XRay Systems

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 Class 2 Device Recall Phillips Endura XRay Systemssee related information
Date Initiated by FirmAugust 23, 2007
Date PostedNovember 10, 2007
Recall Status1 Terminated 3 on September 27, 2010
Recall NumberZ-0060-2008
Recall Event ID 39392
Product Classification Fluoroscopic Image-Intensified System - Product Code JAA
ProductPhilips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option
Code Information Serial numbers: 90, 105, 118, 119, 135, 171, 175, 176, 222, 218, 227, 226, 232, 233, 241, 248, 249, 256, 261, 262, 276, 277, 282, 303, 302, 316, 313, 304, 311, 312, 320, 327, 334, 333, 343, 345, 396
FEI Number 1000524572
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact
425-487-7602
Manufacturer Reason
for Recall		System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.
FDA Determined
Cause 2		Software design
ActionOn 8/23/07, the firm sent out a Safety Notification letter, via certified mail. On 8/29/07, the firm sent out an URGENT - DEVICE CORRECTION letter via regular mail, dated 8/20/07. Both letters advised customers that if the device shuts down during use, it can be restarted within about 1 minute by switching the system off and then on again, using the system on/off buttons. The letter(s) states that software is being developed to correct the problem.
Quantity in Commerce37 units
DistributionNationwide
Total Product Life CycleTPLC 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.
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