Recall Z-0898-06 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare
GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital Fluoroscopic Imaging System.
| Date | May 24, 2006 (initiated Mar 6, 2006) |
| Status | Terminated |
| Reason | Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient. |
| Root cause | Other |
| Action | GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033. |
| Quantity | 291 (213 domestic and 78 OUS) |
| Distribution | Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic o |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023178 | INNOVA 4100 Ge Medical Systems, Inc., Nov 26, 2002 |