Z-0842-2008

GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the...

Name: Z-0842-2008 GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the...
Creator: GE Healthcare
Published: 2007-11-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2007-11-01 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188 on 2007-11-01. The reason FDA records is "The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0842-2008
Status: Terminated
Initiated: 2007-11-01
Posted: 2008-06-10
Terminated: 2011-12-18
Recalling firm: GE Healthcare
Product: GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.
Product code: KPR System, X-Ray, Stationary
Reason for recall: The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE issued a Field Modification Instruction to their field service representatives, released in December 2007, with instructions to replace the labels on the console with the appropriate labeling. Consignees will be visited by GE field service representatives beginning December 2007. All consignees will have the required labels affixed to their units by July 31, 2008.
Quantity in commerce: 400 Units
Distribution: Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia.
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Product code KPR

K993090Class IISilhouette FcGe Medical Systems, Inc. / cleared 1999-10-01

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)