Terminated

GE Healthcare, Proteus XR/a with wall stand model number 600-0301.

FDA Recall Z-0954-2015 · Posted 2015-01-12

Recalling FirmGE Healthcare

Recall StatusTerminated

Product CodeKPR

Date Initiated2014-12-08

Date Terminated2016-02-03

Product Quantity3096 (2486 US, 610 OUS).

Reason for Recall

GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported.

Firm Action

Consignees were sent on 12/8/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 17107, dated December 8, 2014. The letter was addressed to Hospital Administrators /Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact information (For questions in USA call 800-437-1171, For other countries contact your local GE Healthcare Service Representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA: All states in continental US including, Guam, DC. OUS; ARAB EMIRATES, AUSTRIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KUWAIT, LATVIA, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, POLYNESIA, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993090SILHOUETTE FCGe Medical Systems, Inc. · 1999-10-01

Official Source

View FDA Recall →

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