Z-0789-06

iLab Utrasound Imaging System, software controlled Imaging Catheter

Name: Z-0789-06 iLab Utrasound Imaging System, software controlled Imaging Catheter
Creator: Boston Scientific Target
Published: 2006-03-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-03-06 / Terminated

FDA source

Boston Scientific Target began a recall of iLab Utrasound Imaging System, software controlled Imaging Catheter on 2006-03-06. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0789-06
Status: Terminated
Initiated: 2006-03-06
Posted: 2006-04-22
Terminated: 2007-11-28
Recalling firm: Boston Scientific Corporation
Product: iLab Utrasound Imaging System, software controlled Imaging Catheter.
Product code: DQO Catheter, Intravascular, Diagnostic
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)
FDA root cause: Other
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.
Quantity in commerce: 23 units (13 in the US, 10 outside)
Distribution: Product was distributed to 13 US consignees and 10 foreign consignees.
Product codes and lots: Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.

Product code DQO

K051679Class IIIlab Ultrasound Imaging SystemBoston Scientific Corp / cleared 2005-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)