GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
FDA device recall Z-2158-2011 · posted 2011-07-21 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- IWE
- Quantity affected
- 4
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-01-26
- Date posted
- 2011-07-21
- Date terminated
- 2012-08-31
- Location
- Waukesha, WI
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