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Terminated

iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538

FDA Recall Z-1693-2008 · Posted 2008-09-23

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeIYO
Date Initiated2000-04-11
Date Terminated2009-04-06
Product Quantity120 units

Reason for Recall

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.

Firm Action

On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008.

Root Cause

Process control

Distribution Pattern

Product was distributed to a total of 81 consignees in the USA, Hong Kong, Great Britain, Austria and France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072517ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3Boston Scientific Corp · 2007-09-26

Official Source

View FDA Recall →

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

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