PlainRecordsFDA · Medical device recall
GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
- Date posted by the FDA
- July 21, 2011
- Status
- Terminated
- Filed by
- GE Healthcare, LLC
- Product
- GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
- 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.
- Distribution pattern
- Nationwide Distribution
- Quantity
- 4
- Codes and lots
- Part # 5417918-1EN.
- Recall started
- Jan. 26, 2011
- Device type
- Monitor, Patient Position, Light-Beam
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-2158-2011
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement report, recall number Z-2158-2011. The agency record governs; check it and the company before acting.