| Class 2 Device Recall GE OEC 6800 Fluoroscopic xray system | |
Date Initiated by Firm | June 12, 2007 |
Date Posted | June 30, 2007 |
Recall Status1 |
Terminated 3 on November 01, 2011 |
Recall Number | Z-0851-2007 |
Recall Event ID |
38279 |
510(K)Number | K992506 |
Product Classification |
Fluoroscopic x-ray system - Product Code JAA
|
Product | GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. |
Code Information |
Serial numbers: 86-2102, 86-2133, 86-2137, 86-2138, 86-2139, 86-2140, 86-2143, 86-2145, 86-2146, 86-2147, 86-2148, 86-2149, 86-2150, 86-2151, 86-2152, 86-2153, 86-2154, 86-2155, 86-2156, 86-2157, 86-2158, 86-2159, 86-2160, 86-2161, 86-2162, 86-2163, 86-2164, 86-2165, 86-2166, 86-2167, 86-2168, 86-2169, 86-2170, 86-2171, 86-2172, 86-2173, 86-2174, 86-2175, 86-2176, 86-2177, 86-2178, 86-2179, 86-2180, 86-2181, 86-2182, 86-2183, 86-2184, 86-2185, 86-2186, 86-2187, 86-2188, 86-2189, 86-2190, 86-2191, 86-2192, 86-2193, 86-2194, 86-2195, 86-2196, 86-2197, 86-2198, 86-2199, 86-2200, 86-2201, 86-2202, 86-2203, 86-2204, 86-2205, 86-2206, 86-2207, 86-2208, 86-2209, 86-2210, 86-2211, 86-2212, 86-2213, 86-2214, 86-2215, 86-2216, 86-2217, 86-2218, 86-2219, 86-2220, 86-2221, 86-2222, 86-2223, 86-2224, 86-2225, 86-2226, 86-2227, 86-2228, 86-2229, 86-2230, 86-2231, 86-2232, 86-2233, 86-2234, 86-2235, 86-2236, 86-2237, 86-2238, 86-2239 |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
|
For Additional Information Contact | 801-536-4516 |
Manufacturer Reason for Recall | X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems. |
Quantity in Commerce | 102 units |
Distribution | Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JAA
|
|
|
|