Merlin PCS 3650 programmer Model 3330 software
Enforcement
- Recall Number
- Z-1495-2022
- Event ID
- 90530
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- St. Jude Medical, Cardiac Rhythm Management Division
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 10, 2022
- Initiation Date
- June 17, 2022
- Classification Date
- August 2, 2022
- Address
- 15900 Valley View Ct, N/A, Sylmar, CA, 91342-3577, United States
Description
Merlin PCS 3650 programmer Model 3330 software
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725
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