FDA Medical Device Recalls (openFDA)
Boston Scientific: Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300
- Recall number
- Z-0112-06
- Recalling firm
- Boston Scientific
- Product
- Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300
- Status
- Terminated
- Initiated
- 2005-03-14
- Posted
- 2005-11-01
- Terminated
- 2005-12-13
- 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.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K992912"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3001236349
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28