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U.S. Department of Health and Human Services

Class 2 Device Recall System, Nuclear Magnetic Resonance Imaging

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 Class 2 Device Recall System, Nuclear Magnetic Resonance Imagingsee related information
Date Initiated by FirmDecember 09, 2005
Date PostedJanuary 06, 2006
Recall Status1 Terminated 3 on May 20, 2008
Recall NumberZ-0358-06
Recall Event ID 34207
510(K)NumberK940534 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
ProductGyroscan 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 
FEI Number 1000524572
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information ContactSarah Baxter
425-487-7665
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.
FDA Determined
Cause 2		Other
ActionProduct 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 Commerce96
Distribution96 units distributed to 92 U.S. Customers
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.
510(K) Database510(K)s with Product Code = LNH
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