Official recall notice
FDA DeviceClass IINotable
FDA Recall: Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- Recall date
- 2026-06-17
- Brand
- Abbott Medical
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Recommended action
What to do
11182 programs
Product description
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.