Recall Z-0338-2009 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Boston Scientific Corporation
Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasound examination of intravascular pathology. Manufactured by Boston Scientific Corporation, Fremont, CA.
| Date | Dec 16, 2008 (initiated Sep 5, 2008) |
| Status | Terminated |
| Reason | Computer malware: Products may be infected with a worm (computer malware) which could infect a computer network to which it may be connected. |
| Root cause | Process control |
| Action | Customer letters sent on Friday, Sept 5 via FedEx, 2008 to all customers. This letter will be followed up by a customer service visit. Package delivery will be tracked, as well as Reply Verification tracking forms.For further information, please contact firm at 508-652-5594. |
| Quantity | 357 units |
| Distribution | World-wide distribution including USA and countries of Europe, Middle East, Africa, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.