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.
Check against the official notice below — it lists the full affected range.
Abbott is recalling the Merlin Patient Care System (PCS) Model 3650 Software Upgrade Kit due to a software defect. The software version 24.6.1 contains an anomaly where selecting an inappropriate shock energy value may cause the device to continue using a previously programmed energy level without alerting the user that the new selection was not accepted. This affects 4,733 programmers distributed across multiple U.S. states.
The recall involves programmers used to interrogate implantable cardioverter defibrillators (ICDs) that were used between January 22, 2020 and February 6, 2020. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees associated to ICDs that were interrogated from January 22, 2020 to February 6, 2020. Quantity: Software Version 24.6.1 installed into 4733 programmers Lot/code info: Software Version: 24.6.1 Model: 3650, GTIN: 05414734500661 Model: 3330, GTIN: 05414734509725 For affected serial number of programmers see Attachment B.1 Programmers For models of ICDs interrogated by affected programmers see Attachment B.2 Devices.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.