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Class 2 Device Recall System, Nuclear Magnetic Resonance Imaging |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
December 09, 2005 |
Date Posted |
January 06, 2006 |
Recall Status1 |
Terminated 3 on May 20, 2008 |
Recall Number |
Z-0358-06 |
Recall Event ID |
34207 |
510(K)Number |
K940534
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Product Classification |
System, Nuclear Magnetic Resonance Imaging - Product Code LNH
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Product |
Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. |
Code Information |
4397, 5257, 4176, 1052, 4222, 4064, 5024, 4009, 4241, 5313, 1139, 5484, 4328, 5201, 5246, 5381, 4296, 4258, 5277, 4246, 1240, 5297, 5311, 5434, 5512, 506, 4207, 1072, 4089, 5373, 1014, 1078, 4025, 5551, 4131, 5455, 5328, 5379, 5261, 4416, 4206, 1191, 4088, 5195, 5334, 5451, 4383, 5250, 5309, 5342, 4183, 4272, 5268, 5009, 4047, 4254, 4261, 5307, 4102, 5199, 5558, 5315, 5266, 5303, 1061, 4307, 5390, 4267, 4386, 5282, 1113, 5123, 5501, 1062, 4339, 5383, 5478, 5507, 4162, 1015, 5162, 1081, 4170, 5477, 4322, 5515, 4069, 5081, 4201, 354, 5345, 4374, 4146, 1097, 5519, 5314 |
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 |
The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient's image record.
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FDA Determined Cause 2 |
Other |
Action |
Product safety notification sent certified mail to each customer explaining the problem. A mandatory software upgrade to correct the problem will be installed starting the first quarter of 2006 and be completed by the third quarter of 2006. |
Quantity in Commerce |
96 |
Distribution |
96 units distributed to 92 U.S. Customers |
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 = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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