[pending] Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Pending LLM rewrite. Source: FDA_DEVICE Z-2405-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
The recalled product
- Product
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- Manufacturer
- Abbott Medical
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Programmer Model 3650
- Software Model 3330
- GTIN 05414734509725
- Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
Distribution
Distributed nationwide across the United States.
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