Recall Z-2158-2011 ยท IWE Monitor, Patient Position, Light-Beam
GE Healthcare, LLC
GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
| Date | Jul 21, 2011 (initiated Jan 26, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture - Do Not Stare Into Beam) affecting certain Discovery Systems. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare will bring affected systems into compliance. A GE Healthcare Service Representative will provide a product label correction to address this issue. This will be carried out via a Field Modification Instruction (FMVI 408311 planned to be released in June 2011 with an estimated completion date of August 2011. For questions call 262-513-4122. |
| Quantity | 4 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.