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U.S. Department of Health and Human Services

Class 2 Device Recall 1.5T HD Head Neck Spine Array, Model 2416329.

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  Class 2 Device Recall 1.5T HD Head Neck Spine Array, Model 2416329. see related information
Date Initiated by Firm September 20, 2006
Date Posted November 09, 2006
Recall Status1 Terminated 3 on April 13, 2012
Recall Number Z-0163-2007
Recall Event ID 36612
510(K)Number K052621  
Product Classification MRI - Product Code MOS
Product 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System.
Code Information The following Serial Numbers of this device were subject to recall: 101, 201, 202, 203, 204, 205, 206, 207, 208, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 327, 328, and 329.
Recalling Firm/
Manufacturer
USA Instruments Incorporated
1515 Danner Dr
Aurora OH 44202-9273
For Additional Information Contact Robert B. Smith
800-582-2145
Manufacturer Reason
for Recall
The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used.
FDA Determined
Cause 2
Other
Action The user/customers were notified of this recall with an ''Urgent Customer Safety Notification'' which was sent to the user/customers via Certified mail per recall letter dated 09/20/2006. The notification informs the customer(s) of this potential problem and the three (3) conditions under which this problem (patient becoming burned) could possibly occur. The notification goes on to inform the customers that the firm will be upgrading all 1.5T HD Head Neck & Spine Arrays so as to eliminate this potential hazard, at no cost to the customer and that a Service Representative will be contacting the customer in order to make arrangements to upgrade the coil on-site. A toll-free telelphone no. is provided in the notification letter for questions and/or comments. Lastly, the recall notification provides interim instructions which the customer should follow. The operator/technician should: ask that the patients place their hands at their sides during a scan; immediately discontinue the scan if the patient undergoing the scan starts to move; and stay in constant visual and oral contact with the patient undergoing the scan at all times. For the 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System, The user/customers were notified of this recall with an ''Urgent Customer Safety Notification'' which was sent to the user/customers via Certified mail per recall letter dated 10/13/2006.
Quantity in Commerce 30 [24 distributed in the U.S and 6 - worldwide]
Distribution Worldwide, including USA, (states of CA, NJ, PA, MN, IA, MA, WI, WA, and FL) Switzerland, the United Kingdom, France, Canada and Finland.
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.
510(K) Database 510(K)s with Product Code = MOS and Original Applicant = USA INSTRUMENTS, INC.
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