Z-0112-06

Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System...

Name: Z-0112-06 Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System...
Creator: Boston Scientific
Published: 2005-03-14
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-03-14 / Terminated

FDA source

Boston Scientific began a recall of Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300 on 2005-03-14. The reason FDA records is "The device has the potential for overheating its transformer and has the potential for fire hazard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0112-06
Status: Terminated
Initiated: 2005-03-14
Posted: 2005-11-01
Terminated: 2005-12-13
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: The device has the potential for overheating its transformer and has the potential for fire hazard.
FDA root cause: Other
Action: The firm sent notification letters to its consignees on April 1, 2005. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the SAM unit.
Quantity in commerce: 69 units distributed worldwide
Distribution: 32 units have been distributed throughout the US, and 37 units distributed internationally.
Product codes and lots: All lots

Product code DQK

K992912Class IICardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter and Radii CathCardiac Pathways Corp. / cleared 2000-03-08

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)