FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
- Recall number
- Z-2158-2011
- Recalling firm
- GE Healthcare, LLC
- Product
- GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
- Status
- Terminated
- Initiated
- 2011-01-26
- Posted
- 2011-07-21
- Terminated
- 2012-08-31
- 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
- Lot, serial or model codes
- Part # 5417918-1EN.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWE
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28