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U.S. Department of Health and Human Services

Class 2 Device Recall General XRay System types with Digital Spot Imaging (DSI)

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 Class 2 Recall
General XRay System types with Digital Spot Imaging (DSI)
see related information
Date Posted August 25, 2008
Recall Status1 Terminated on September 28, 2010
Recall Number Z-2160-2008
Recall Event ID 48602
Premarket Notification
510(K) Number
K920793 
Product Classification Camera, X-Ray, Fluorographic, Cine Or Spot - Product Code IZJ
Product General X-Ray System types with Digital Spot Imaging (DSI) software
Code Information Software version: rel 6 serial numbers: 8, 18, 31, 40, 41, 45, 51, 52, 62, 63, 67, 71, 78, 79, 83, 84, 87, 88, 99, 100, 102, 104, 105, 106, 112, 116, 117, 118, 119, 127, 131, 132, 134, 136, 143, 146, 149, 153, 157, 163, and 164
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall
X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).
FDA Determined
Cause 2
DESIGN: Software Design
Action On 5/20/08 the firm issued an URGENT - DEVICE CORRECTION letter to the consignees advising of the problem, requesting consignees to check the stored or printed images to ensure that it represents the data and images captured from the examination. The firm will issue a Field Change Order to their service representatives providing new software, when software is available. This should be issued by the end of June.
Quantity in Commerce 41 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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