Recall Z-0064-06 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Boston Scientific
Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0
| Date | Oct 19, 2005 (initiated Feb 18, 2005) |
| Status | Terminated |
| Reason | The device has the potential for overheating its transformer and has the potential for fire hazard. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.