Recall Z-2733-2011 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
St Jude Medical CRMD
SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia
| Date | Jul 5, 2011 (initiated Mar 31, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM |
| Root cause | Software change control |
| Action | St. Jude Cardiac Rhythm Management Division sent an "Important Product Correction" letter on March 25, 2011 to all affected customers. The letter explains the reason for the recall and provided recommendations including a software upgrade by SJM Field Clinical Engineer or Technical Services. Customers were recommended to fill out and return a "Physician Acknowledgement Form". For additional information please contact your local St.Jude Medical Sales Representative, Field Clinical Engineer or the Technical Services Department at 800-722-3774 |
| Quantity | 83 units |
| Distribution | Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081365 | SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR St Jude Medical, Aug 15, 2008 |