Reported Apr 22, 2020 · Terminated
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model…
Abbott
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
- Lot codes and dates
- Software Version24.6.1
- Model3650
- GTIN05414734500661
- Model3330
- GTIN05414734509725 For affected serial number of programmers see Attachment B.1 Programmers For models of ICDs interrogated by affected programmers see Attachment B.2 Devices
- Amount recalled
- Software Version 24.6.1 installed into 4733 programmers
Where it was sold
Why it was recalled
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
This product could cause temporary or reversible health problems — stop using it.
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