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Class 2 Device Recall General XRay System types with Digital Spot Imaging (DSI) |
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Date Initiated by Firm |
May 23, 2008 |
Date Posted |
August 25, 2008 |
Recall Status1 |
Terminated 3 on September 28, 2010 |
Recall Number |
Z-2160-2008 |
Recall Event ID |
48602 |
510(K)Number |
K920793
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Product Classification |
X-Ray - Product Code IZJ
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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 WA 98021-8431
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For Additional Information Contact |
Sarah Baxter 425-487-7665
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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).
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FDA Determined Cause 2 |
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
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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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510(K) Database |
510(K)s with Product Code = IZJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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