Recall Z-2238-2010 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare, LLC
Innova 2000, manufactured by GE Medical Systems, SCS
| Date | Aug 19, 2010 (initiated Jun 10, 2010) |
| Status | Terminated |
| Reason | A hardware component (potentiometer and encoder)mismatch in Innova 2000 digital fluoroscopic imaging systems may cause a Source to Image Distance (SID) failure, which will cause the imager to fail to detect the distance between the imager and the patient. This will result in loss of the x-ray image if the recovery process is not performed. The error message to use the Emergency Back-Out Button for |
| Root cause | Other |
| Action | GE Healthcare sent a GE "Urgent Medical Device Correction" dated June 9, 2010letter to consignees. The letter was addressed to Hospital Administrators / Risk Mangers; Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details; Safety Instruction; Product Correction and Contact Information. The letter detailed the method for identifying SID failure and the use of the emergency back-out buttoms to recover the X-ray image. A GE service representative will affix a label to the device on-site to remind operators how to recover |
| Quantity | 885 |
| Distribution | Worldwide distribution: States of AL, AZ, AR, CA, CO, CT,DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV,NH, NJ, NM, NH,NC, ND, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and countries of VENEZUELA, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SYR |
| FDA record | Open on fda.gov |