Device product
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Z-2405-2026
Product summary
- Firm
- Abbott Medical
- Event
- Event 98963
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11182 programs
- Official record key
device-enforcement:Z-2405-2026
Official wording
Reason: Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Code information: Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
Distribution pattern: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet
Derived failure modes
-
Device software or design
Software malfunction