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.
This recall has been terminated (originally issued May 20, 2013).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- April 10, 2013
- Posted
- May 20, 2013
- Terminated
- November 26, 2013
- Recall Number
- Z-1339-2013
- Quantity
- 1
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution including DC and PR
Root Cause
Software change control
Action Taken
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.