GE Healthcare Definium 8000.Model # 5131070. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. The Revolution XR/

FDA device recall Z-0528-2010 · posted 2009-12-16 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction may occur, which could result in the tabletop brakes falling to engage when the control foot pedal is released to lock the floating tabletop in place.

Action taken

A GE Healthcare "Urgent Medical Device Correction" letter dated April 9, 2009 was issued to customers. The letter was addressed to Hospital Administrators/Managers of Radiology and Radiologists. The letter described the Product Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. Operators should verify that the tabletop is locked before the patient is loaded on or off the table. A Field Modification will be performed on the affected products. A GE Healthcare Field Engineer will schedule a field visit to make this modification. Direct questions or concerns regarding the recall to your local GE Healthcare service representative or by calling 1-262-853-7685.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KPR

Quantity affected

5,943 of total product

Distribution

Worldwide Distribution -- UNITED STATES (including Puerto Rico), VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKS AND CAICOS ISLANDS, TURKEY, TUNISIA, TRINIDAD AND TOB

Date initiated

2009-08-13

Date posted

2009-12-16

Date terminated

2012-05-24

Location

Waukesha, WI

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