LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated 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 February 23, 2012).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- December 19, 2011
- Posted
- February 23, 2012
- Terminated
- October 25, 2012
- Recall Number
- Z-1096-2012
- Quantity
- 1
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Boston Scientific is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with this issue.
Distribution
Nationwide Distribution, USA - including the states CA, MA, MI, NC, OK, PA, RI, TX, and WA.
Lot / Code Info
Software version 7.2
Root Cause
Software design
Action Taken
Beginning on December 19, 2011, for the patients that have attempted to set-up their communicators, Boston Scientific called the patients and their associated LATITUDE clinics to let them know that they can now complete the set-up.
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