Recall Z-1067-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution, high signal-to-noise ratio, with short scan times. The Signa Excite MR system with Surgical Option is indicated for us
| Date | Feb 21, 2012 (initiated Dec 15, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue due to the failure of the transfer board release lever associated with the OR Compatible patient transfer table of your Optima MR450w MR Surgical Suite. |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare, sent a Urgent Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed discontinue use of OR Compatible table until issue is corrected. GE Healthcare will correct all affected systems by providing a replacement table cradle incorporating design changes to the cradle release lever mechanism at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. Contact your local service re |
| Quantity | 2 |
| Distribution | Worldwide Distribution -- USA including Wisconsin and the country of Austria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043262 | GE SIGNA EXCITE MR SURGICAL OPTION GE Healthcare, Jan 12, 2005 |