Z-0691-2007

HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled...

Name: Z-0691-2007 HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled...
Creator: Boston Scientific Corporation
Published: 2007-01-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-01-24 / Terminated

FDA source

Boston Scientific Corporation began a recall of HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system) on 2007-01-24. The reason FDA records is "Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0691-2007
Status: Terminated
Initiated: 2007-01-24
Posted: 2007-03-31
Terminated: 2007-12-12
Recalling firm: Boston Scientific Corporation
Product: HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
Product code: MNB Device, Thermal Ablation, Endometrial
Reason for recall: Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment
FDA root cause: Other
Action: Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product.
Quantity in commerce: 2 units
Distribution: Worldwide-USA, UK, Denmark, Italy, and France
Product codes and lots: Unit Numbers: IN0339JC, IN0340JC,

Product code MNB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)