Z-0358-06

Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging

Name: Z-0358-06 Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging
Creator: Philips Medical Systems North America Co. Phillips
Published: 2005-12-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-12-09 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging on 2005-12-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0358-06
Status: Terminated
Initiated: 2005-12-09
Posted: 2006-01-06
Terminated: 2008-05-20
Recalling firm: Philips North America LLC
Product: Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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

Product code LNH

K940534Class IIGyroscan T10-Nt (Release 4 Series Software)Philips Medical Systems, Inc. / cleared 1994-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)