Recall Z-1096-2012 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific CRM Corp
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.
| Date | Feb 23, 2012 (initiated Dec 19, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 1 |
| Distribution | Nationwide Distribution, USA - including the states CA, MA, MI, NC, OK, PA, RI, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.