GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 2225870, 2225881, and 2225882. Intended to be used for general purpose radiography and tomography.
FDA Recall Z-0457-2010 · Posted 2009-11-25
Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeIZZ
Date Initiated2009-07-30
Date Terminated2016-05-19
Product Quantity1046
Reason for Recall
GE Healthcare has recently become aware that table lock safety features, which are provided with Compax
40E X-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement
that may impact patient safety.
Firm Action
Consignees in US and Canada were sent on July 31, 2009 a GE Healthcare "Urgent Medical device Correction" letter dated July 30, 2009. The letter was addressed to Hospital Administrators/ Risk mangers; Radiology Department Mangers; Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction, and Contact Information. The letter instructs customers that the table manual mechanical lock is provided with the system and should be engaged when loading or unloading patients to ensure the tabletop is stabilized and not moving. For the rest of the world, the customer letter was dated October 22, 2009 and was mailed October 30, 2009.
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- USA, including states of AL, AK, AZ, AR, CA, CO, CT, DC,FL, GA, HI, ID, IL , IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH,NJ, NM, NY, NC, OH, OK OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of UNITED KINGDOM, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SAUDI ARABIA, PUERTO RICO, PORTUGAL NEW CALEDONIA, MARTINIQUE, KOREA, JAPAN, JAMAICA, ITALY, ISRAEL, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, EGYPT, DOMINICAN, CHINA, CANDA, BRAZIL AUSTRIA, and AUSTRALIA.
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.