Philips Medical Systems . Class II

Company: Philips Medical Systems North America Co.
Date of Enforcement Report:1/18/2006
Class:lI

PRODUCT
Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. Recall # Z-0358-06

REASON
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..

CODE
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
Recalling Firm: Philips Medical Systems North America Co, Bothell, WA, by letter on December 9, 2005.
Manufacturer: Philips Medical Systems Ned Bv, Best, Netherlands. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
96 units

DISTRIBUTION
Nationwide

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.