Merlin PCS 3650 Software Upgrade Kit — Class II medical device recall Z-1700-2020
Terminated recall by Abbott, reported 2020-04-22, distributed in AK, AR, AZ, CA, CO, DC, DE, FL…. Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value
| Recall number | Z-1700-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott, Sylmar, CA, United States |
| Recall initiated | 2020-02-28 |
| Classified | 2020-04-10 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2024-04-18 |
| Distributed | 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 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05414734500661, 05414734509725 |
| Model numbers | 3330, 3650 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1700-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.