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GE Proteus XR/a Radiographic System. GE Medical… recallZ-1790-2012 · General Electric Med Systems LLC · initiated May 31, 2006

Class II Terminated All recalls posted in June 2012

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from General Electric Med Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

FDA root cause category: Device Design

What the company is doing

GE Healthcare sent an "URGENT SAFETY INFORMATION" letter dated May 31, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included new operator instructions and warning labels.

Recall details

Recall number
Z-1790-2012
Recall class
Class II
Status
Terminated
Initiated by the company
May 31, 2006
Posted by the FDA
Jun 8, 2012
Recalling firm
General Electric Med Systems LLC
Quantity
3,796 units
Product code
KPR
FDA submissions
K993090
Distribution
Worldwide Distribution.

Product description

GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.

Code information (models, lots, serial numbers)

All serial numbers

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.

Sources and updates

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