Recall Z-0112-06 ยท DQK Computer, Diagnostic, Programmable
Boston Scientific
Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300
| Date | Nov 1, 2005 (initiated Mar 14, 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 April 1, 2005. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the SAM unit. |
| Quantity | 69 units distributed worldwide |
| Distribution | 32 units have been distributed throughout the US, and 37 units distributed internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992912 | CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH Cardiac Pathways Corp., Mar 8, 2000 |