Z-0064-06

Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM)...

Name: Z-0064-06 Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM)...
Creator: Boston Scientific
Published: 2005-02-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-02-18 / Terminated

FDA source

Boston Scientific began a recall of Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0 on 2005-02-18. 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-0064-06
Status: Terminated
Initiated: 2005-02-18
Posted: 2005-10-19
Terminated: 2006-01-30
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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 2/18/05 and 5/18/05 via FedEx. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the PAM unit component.
Distribution: Product was released for distribution to 38 consignees in US nationwide. International distribution includes EU and Canada. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.
Product codes and lots: All lots

Product code DRF

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)