Recall Z-1339-2013 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific CRM Corp
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.
| Date | May 20, 2013 (initiated Apr 10, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Software change control |
| Action | 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. |
| Quantity | 1 |
| Distribution | Nationwide Distribution including DC and PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.