{"url_path":"/fda/device/recalls/Z-2306-2026","section_key":"summary","section_title":"DEVICE Recall: GE Medical Systems China Co., Ltd. — MAC 5 A4 Resting ECG Analysis System 855001-001;  MAC 5 A5 Resting ECG Analysis System 8855002-001.  Electrocardiograph","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2306-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"GE Medical Systems China Co., Ltd."},"word_count":115,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2306-2026\n\n**Recalling firm:** GE Medical Systems China Co., Ltd.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-21\n**Report date:** 2026-06-10\n\n## Product\nMAC 5 A4 Resting ECG Analysis System 855001-001;  MAC 5 A5 Resting ECG Analysis System 8855002-001.  Electrocardiograph\n\n## Reason\nSoftware in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.\n\n## Affected lots\nSoftware version 3.00  855001-001, UDI-DI 00195278276070  8855002-001, UDI-DI 00195278276124\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom."}