FDA Device recall Z-1700-2020
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, d…
- FDA Device
- Class II
- terminated
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, d… by Abbott, citing 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 programme….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1700-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-28 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott |
| Distribution | AK, 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, WV |
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.
Identifiers
| code_info | Software Version: 24.6.1 Model: 3650, GTIN: 05414734500661 Model: 3330, GTIN: 05414734509725 For affected seri…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1700-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.