GE Healthcare Proteus XR/a Radiographic X-ray System, Model… recallZ-0842-2008 · GE Healthcare · initiated Nov 1, 2007

Terminated All recalls posted in June 2008

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from GE Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number: Z-0842-2008
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Nov 1, 2007
Posted by the FDA: Jun 10, 2008
Recalling firm: GE Healthcare
Quantity: 400 Units
Product code: KPR
FDA submissions: K993090
Distribution: Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia.

Product description

GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.

Code information (models, lots, serial numbers)

Show the full code information (6k characters)

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Other devices under the same FDA submission

1 device cleared under K993090 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Proteus XRa
GE Hualun Medical Systems Co., Ltd · System, x-ray, stationary
2 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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