Recall Z-1693-2008 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Boston Scientific Corporation
iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538
| Date | Sep 23, 2008 (initiated Apr 11, 2000) |
| Status | Terminated |
| Reason | Improperly terminated wires on a component of the iLab Acquisition processor power supply could cause the processor to lock-up or stop, and prolong the patients procedure. |
| Root cause | Process control |
| Action | On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008. |
| Quantity | 120 units |
| Distribution | Product was distributed to a total of 81 consignees in the USA, Hong Kong, Great Britain, Austria and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072517 | ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 Boston Scientific Corp, Sep 26, 2007 |