Z-0164-2007

3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System

Name: Z-0164-2007 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System
Creator: USA Instruments Incorporated
Published: 2006-09-20
License: https://open.fda.gov/license/

GE Healthcare Coils / initiated 2006-09-20 / Terminated

FDA source

USA Instruments Incorporated began a recall of 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System on 2006-09-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0164-2007
Status: Terminated
Initiated: 2006-09-20
Posted: 2006-11-09
Terminated: 2012-04-13
Recalling firm: GE Healthcare Coils
Product: 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.
Product code: MOS Coil, Magnetic Resonance, Specialty
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 root cause: 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: 12 distributed in the US.
Distribution: Worldwide, including USA, (states of CA, NJ, PA, MN, IA, MA, WI, WA, and FL) Switzerland, the United Kingdom, France, Canada and Finland.
Product codes and lots: The following Serial Numbers of this device were subject to recall: 101, 102, 201, 202, 203, 204, 205, 206, 207, 309, 310.

Product code MOS

K052916Class IIUSA Instruments 3.0T Brain/spine ArrayUsa Instruments, Inc. / cleared 2005-11-09

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)