FDA DevicesClass II
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 33...
Published: June 17, 2026Recall ID: Z-2405-2026Category: devicesCountry: US
Reason for Recall / Hazard
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Product Description & Identification
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Affected Products
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Additional Source Details
| Field | Value |
|---|---|
| City | Sylmar |
| State | CA |
| Event id | 98963 |
| Address 1 | 15900 Valley View Ct |
| Address 2 | N/A |
| Code info | Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region) |
| Postal code | 91342-3577 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 11182 programs |
| Reason for recall | Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260512 |
| Initial firm notification | Letter |
| Center classification date | 20260611 |
Overview
- Recalling FirmAbbott Medical
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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