Recall Z-1700-2020 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Abbott
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
| Date | Feb 28, 2020 |
| Status | Terminated |
| Reason | Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained. |
| Root cause | Under Investigation by firm |
| Action | On 02/28/2020, the frim sent all US consignees an "IMPORTANT MEDICAL DEVICE CORRECTION" letter via USPS three to five-day ground service. The customer notification informed customer that they had recently deployed a Patient Care System (PCS) programmer software that contained an anomaly that may result in specific programming changes not being stored in the device. The Recalling Firm explained that when using the affected programmer software to make certain programming changes, the changes may appear to have been successfully programmed but the device could remain at previously programmed se |
| Quantity | Software Version 24.6.1 installed into 4733 programmers |
| Distribution | U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees associated to ICDs that were interrogated from January 22, 2020 to F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.