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Terminated

iLab Utrasound Imaging System, software controlled Imaging Catheter.

FDA Recall Z-0789-06 · Posted 2006-04-22

Recalling FirmBoston Scientific Target
Recall StatusTerminated
Product CodeDQO
Date Initiated2006-03-06
Date Terminated2007-11-28
Product Quantity23 units (13 in the US, 10 outside)

Reason for Recall

Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only)

Firm Action

The firm initiated recall actions on March 6, 2006. On March 21, 2006, the firm issued notification letters to all appropriate personnel at hospitals and user facilities to inform them of actions taken by Boston Scientific to remediate any risks.

Root Cause

Other

Distribution Pattern

Product was distributed to 13 US consignees and 10 foreign consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051679ILAB ULTRASOUND IMAGING SYSTEMBoston Scientific Corp · 2005-07-14

Official Source

View FDA Recall →

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

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