FDA-Device2013-05-29Class II
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.
Boston Scientific CRM Corp
Hazard
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.
Sold states
Nationwide Distribution including DC and PR
Affected count
1
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1339-2013Don't want to check this manually?
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