Company: Abbott
Date of Enforcement Report: 4/22/2020
Class II
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.
Recall Number: Z-1700-2020
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/MANUFACTURER
Abbott on 2/28/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,656 units
DISTRIBUTION
US Nationwide