FDA Medical Device Recalls (openFDA)
Boston Scientific Target: iLab Utrasound Imaging System, software controlled Imaging Catheter.
- Recall number
- Z-0789-06
- Recalling firm
- Boston Scientific Target
- Product
- iLab Utrasound Imaging System, software controlled Imaging Catheter.
- Status
- Terminated
- Initiated
- 2006-03-06
- Posted
- 2006-04-22
- Terminated
- 2007-11-28
- Reason
- 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)
- 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
- 23 units (13 in the US, 10 outside)
- Distribution
- Product was distributed to 13 US consignees and 10 foreign consignees.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K051679"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 2939204
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28