Recall Z-1339-2013— Boston Scientific CRM Corp
Class II · Terminated
Class II FDA medical device recall by Boston Scientific CRM Corp, initiated 2013-04-10, terminated 2013-11-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Boston Scientific CRM Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-10
- Terminated
- 2013-11-26
- Firm location
- Saint Paul, MN, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.