Recall Z-1516-2008 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
GE Healthcare
GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option.
| Date | Sep 29, 2008 (initiated Oct 21, 2007) |
| Status | Terminated |
| Reason | Incorrect dose data: GE Healthcare has found that after 6 days and 4 hours without performing a system reset or a system reboot (turning it off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100 with Bolus option) may be underestimated by up to 50%. In order to avoid this issue, it is necessary to perform a system reset or reboot every day. GE Healthcare is working on a c |
| Root cause | Nonconforming Material/Component |
| Action | GE sent all customers with affected units a letter on 11/15/07 titled Urgent Medical Device Correction. In the US this was sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX overnight Delivery). The letter was sent to 3 titles within the affected accounts; Hospital Administrator, Manager of Radiology/Cardiology and Radiologist/ Cardiologist. A correction letter identified a short term recommendation to perform a system reset or reboot every day and stated that a software correction will be installed a |
| Quantity | 146 total |
| Distribution | Worldwide Distribution: USA, Argentina, Australia, Canada, China, Germany, Japan, Mexico and Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042053 | INNOVA 4100, INNOVA 3100 Ge Medical Systems, Inc., Aug 26, 2004 |