FDA Medical Device Recalls (openFDA)
Boston Scientific CRM Corp: LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
- Recall number
- Z-1339-2013
- Recalling firm
- Boston Scientific CRM Corp
- Product
- LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
- Status
- Terminated
- Initiated
- 2013-04-10
- Posted
- 2013-05-20
- Terminated
- 2013-11-26
- Reason
- Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.
- Root cause
- Software change control
- Action
- Boston Scientific CRM Corp began re-faxing the 4,912 previously illegible PMR notifications on April 10, 2013 and completed on April 15, 2013, successfully fulfilling labeling expectations that these notifications be communicated to the clinic. For questions regarding this recall call 651-582-4000.
- Quantity
- 1
- Distribution
- Nationwide Distribution including DC and PR
- Lot, serial or model codes
- n/a
- 510(k) numbers
- not on file
- PMA numbers
- ["P910077S123"]
- Product code
- LWS
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- 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