Philips Medical Systems North America Co. Phillips Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
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
Products Sold
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
Philips Medical Systems North America Co. Phillips is recalling Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026