PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 21, 2015 Initiated: December 8, 2014 #Z-0954-2015

Product Description

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

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.

Details

Recalling Firm
GE Healthcare
Units Affected
3096 (2486 US, 610 OUS).
Distribution
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
GE Healthcare, Proteus XR/a with wall stand model number 600-0301.. Recalled by GE Healthcare. Units affected: 3096 (2486 US, 610 OUS)..
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 21, 2015. Severity: Moderate. Recall number: Z-0954-2015.