Terminated

GE Healthcare Definium 8000.Model # 5131070. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic Images of human anatomy.The device is not intended for mammographic applications.

FDA Recall Z-0528-2010 · Posted 2009-12-16

Recalling FirmGE Medical Systems, LLC

Recall StatusTerminated

Product CodeKPR

Date Initiated2009-08-13

Date Terminated2012-05-24

Product Quantity5,943 of total product

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution -- UNITED STATES (including Puerto Rico), VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKS AND CAICOS ISLANDS, TURKEY, TUNISIA, TRINIDAD AND TOBAGO, THAILAND, TAIWAN, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL POLAND, PANAMA, PAKISTAN, NORWAY NEW ZEALAND, NETHERLANDS , MEXICO MARTINIQUE, MALTA, MALAYSIA, LITHUANIA, LABA NON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKSTAN, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, GUAM, GREECE, GERMANY, FRENCH POLYNESIA, FRANCE FINLAND , ECUADOR, DENMARK CZECH REPUBLIC, CROATIA, COLUMBIAN, CHINA, CHILE , CANDA, BULGARIA, BRAZIL, BOSNIA, BELGIUM AUSTRIA, AUSTRALIA, and ARGENTINA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051967REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESISGE Healthcare · 2005-08-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.