Recall Z-2405-2026— Abbott Medical
Class II · Ongoing
Class II FDA medical device recall by Abbott Medical, initiated 2026-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software. Reason: Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test..
- Recalling firm
- Abbott Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-12
- Firm location
- Sylmar, CA, United States
Product description
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.