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Terminated

GE Healthcare Definium 8000, Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

FDA Recall Z-0584-2012 · Posted 2012-01-11

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2011-11-22
Date Terminated2012-10-16
Product Quantity631

Reason for Recall

GE Healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the Definium 8000 and Discovery XR650 image pasting systems that may impact patient and user safety. The patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. Thi

Firm Action

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 17, 2011 to its customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The customers were instructed to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions; discontinue use of the patient barrier and remove from service (away from patients) if either one the rotating arm locking levers is damaged (does not hold the rotating arm in place when engaged); take extra precautions to hold the patients barrier rotating arm during release of the locking lever and repositioning of the arm and store the rotating arms in the lowest pivot position (down) when not in use. The letter also stated that the patient barrier may continue to be used if the rotating arm locking lever securely holds the rotating arm in place when it is engaged. Additionally, GE Healthcare will modify the rotating arms to restore the residual friction so that the arm will retain position (rather than swing freely) while the locking levers are disengaged. Also, GE will update the product labeling to improve awareness and identify the hazard relative to proper storage. If you have any questions, call Center in US: 800-437-1171; Japan: 0120-055-919 and for other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID,IL, IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY,NC, OH, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, NORWAY, NEW ZEALAND, NETHERLANDS, MARTINIQUE, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, HONG KONG, GREECE, GERMANY, FRENCH POLYNESIA, FRANCE, FINLAND, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BOSNIA AND Herzegovina, BELGIUM, AUSTRIA, AUSTRALIA, and ARGENTINA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050704MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONINGGeneral Electric Co. · 2005-04-08

Official Source

View FDA Recall →

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

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