{"url_path":"/fda/device/recalls/Z-2405-2026","section_key":"summary","section_title":"DEVICE Recall: Abbott Medical — Merlin\" Patient Care System (PCS) software  Merlin\" PCS 3650 programmer Model 3330 software","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-12","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2405-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Abbott Medical"},"word_count":153,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2405-2026\n\n**Recalling firm:** Abbott Medical\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-12\n**Report date:** 2026-06-17\n\n## Product\nMerlin\" Patient Care System (PCS) software  Merlin\" PCS 3650 programmer Model 3330 software\n\n## Reason\nSoftware malfunction may occur during pacing capture threshold test of pacemaker resulting in  programmer not successfully communicating the command to terminate the test.\n\n## Affected lots\nProgrammer Model 3650; Software Model 3330;  GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)\n\n## Distribution\nUS Nationwide distribution including in the states of  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, \tGA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, \tNY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet"}