Recall Z-0164-2007 ยท MOS Coil, Magnetic Resonance, Specialty
USA Instruments Incorporated
3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.
| Date | Nov 9, 2006 (initiated Sep 20, 2006) |
| Status | Terminated |
| Reason | 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. |
| 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 t |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052916 | USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY Usa Instruments, Inc., Nov 9, 2005 |