FDA Recall
Terminated
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.
Recall: Z-0338-2009
·
Initiated September 5, 2008
Recall
- Recall Number
- Z-0338-2009
- Event Number
- 49420
- Firm
- Boston Scientific Corporation
- FEI Number
- 2939204
- Product Code
- IYO
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 5, 2008
- Posted
- December 16, 2008
- Terminated
- May 18, 2009
- Address
- 47900 Bayside Pkwy, Fremont, CA, 94538-6515
Description
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.
Reason
Computer malware: Products may be infected with a worm (computer malware) which could infect a computer network to which it may be connected.
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.
Distribution
World-wide distribution including USA and countries of Europe, Middle East, Africa, and Japan.
Quantity
357 units