Z-2158-2011

GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system

Name: Z-2158-2011 GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
Creator: GE Healthcare, LLC
Published: 2011-01-26
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-01-26 / Terminated / root cause: labeling and UDI

FDA source

GE Healthcare, LLC began a recall of GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system on 2011-01-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2158-2011
Status: Terminated
Initiated: 2011-01-26
Posted: 2011-07-21
Terminated: 2012-08-31
Recalling firm: GE Healthcare
Product: GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system
Product code: IWE Monitor, Patient Position, Light-Beam
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 4
Distribution: Nationwide Distribution
Product codes and lots: Part # 5417918-1EN.

Product code IWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)