FDA
Food and Drug Administration · Recall Z-2405-2026 · May 12, 2026Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Abbott Medical
The hazard
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Programmer Model 3650Model Software Model 3330Model GTIN 05414734509725UPC 05414734509725Would you have heard about this one?
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