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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 13, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 08, 2005
Recall Number Z-1028-04
Recall Event ID 29229
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Trolley for Intera/NT MRI System
Code Information The firm uses site numbers instead of serial numbers: Site Numbers: 105313, 104340, 105929, 84700, 103811, 103904, 504899, 102157, 103592, 85500, 87355, 86404, 103247, 87604, 505682, X1595, 101595, 87062, 103215, 86012, 103620, 101070, 104897, 105486, 83306, 86184, 100826, 84899, 100629, 87527, 84820, 100786, 86085, X1649, 504412, 504741, 87365, 102786, 104886, 103688, 86570, 102095, 103665, 100459, 103611, 102353, 104102, 100462, 103101, 103540, 85158, 103450, 102671, 102896, 102698, 83080, 103782.
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall		 Patient and MRI tabletop may fall if the tabletop is not positioned correctly on the MRI trolley.
FDA Determined
Cause 2		 Other
Action The firm sent a letter via certified mail to all customers on May 13, 2004 instructing their customers to check the position of the tabletop to ensure it is correctly aligned on the trolley. The firm is implementing a design modification beginning May 13, 2004. A field service engineer will contact the customers to arrange for installation of the retrofit for the trolley.
Quantity in Commerce 57 devices
Distribution Product was distributed to hospitals and medical centers nationwide.
Total Product Life Cycle TPLC 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.
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