Recall Z-2221-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
| Date | Aug 17, 2012 (initiated Oct 19, 2007) |
| Status | Terminated |
| Reason | X-ray units did not meet manufacturer's specification for linearity. |
| Root cause | Nonconforming Material/Component |
| Action | GE updated their user manual and changed their internal specifications to match those of the CFR In addition, a software code correction was to be made to forward productions in order to correct the reported defect. *** This recall issued was previously classified under an incorrect recall number. It is being reclassified with a new number. *** |
| Quantity | 175 units |
| Distribution | Worldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Mar 12, 2001 |