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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.

FDA Recall Z-0338-2009 · Posted 2008-12-16

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeIYO
Date Initiated2008-09-05
Date Terminated2009-05-18
Product Quantity357 units

Reason for Recall

Computer malware: Products may be infected with a worm (computer malware) which could infect a computer network to which it may be connected.

Firm 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.

Root Cause

Process control

Distribution Pattern

World-wide distribution including USA and countries of Europe, Middle East, Africa, and Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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