FDA DeviceClass IINotable

FDA Recall: Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

Date: 2026-06-17
Brand: Abbott Medical
Category: Medical Device
FDA Class: Class II

Description

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

Hazard

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

Remedy

11182 programs

Related Recalls