FDA Medical Device Recalls (openFDA)
Boston Scientific: Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0
- Recall number
- Z-0064-06
- Recalling firm
- Boston Scientific
- Product
- Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0
- Status
- Terminated
- Initiated
- 2005-02-18
- Posted
- 2005-10-19
- Terminated
- 2006-01-30
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DRF
- 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