GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Recall Z-1248-2015 · Posted 2015-03-06
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeKPR
Date Initiated2015-01-30
Date Terminated2015-09-15
Product Quantity192 (131 US, 61 OUS).
Reason for Recall
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
Firm Action
Consignees were sent on 1/30/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#17108 dated January 30, 2015. 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 contact 800-437-1171. Outside the US contact your local GE Healthcare Service Representative.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI,and WV, and the countries of ARGENTINA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, IRELAND, ITALY, JAPAN, NEW ZEALAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, and UNITED KINGDOM.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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