Recall Z-1700-2020— Abbott
Class II · Terminated
Class II FDA medical device recall by Abbott, initiated 2020-02-28, terminated 2024-04-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Abbott
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-28
- Terminated
- 2024-04-18
- Firm location
- Sylmar, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.