Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numb
FDA device recall Z-0112-06 · posted 2005-11-01 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- Reason for recall
- The device has the potential for overheating its transformer and has the potential for fire hazard.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 69 units distributed worldwide
- Distribution
- 32 units have been distributed throughout the US, and 37 units distributed internationally.
- Date initiated
- 2005-03-14
- Date posted
- 2005-11-01
- Date terminated
- 2005-12-13
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH (K992912) | Cardiac Pathways Corp. | 2000-03-08 |