{"url_path":"/fda/device/recalls/Z-2316-2026","section_key":"summary","section_title":"DEVICE Recall: GE Medical Systems, LLC — Allia IGS 7 Pulse angiographic X-ray system","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2316-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"GE Medical Systems, LLC"},"word_count":138,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2316-2026\n\n**Recalling firm:** GE Medical Systems, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-20\n**Report date:** 2026-06-17\n\n## Product\nAllia IGS 7 Pulse angiographic X-ray system\n\n## Reason\nGE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.\n\n## Affected lots\nUDI-DI: 00195278719720; Serial Numbers: D3-23-024, D3-23-029, D3-24-001, D3-24-002, D3-24-005, D3-24-006, D3-24-008, D3-24-009, D3-24-010, D3-24-013, D3-24-014, D3-24-016, D3-24-019, D3-24-020, D3-24-021, D3-24-023, D3-24-025, D3-25-001, D3-25-002, D3-25-003, D3-25-005, D3-25-006, D3-25-007, D3-25-008, D3-25-009, D3-25-010, D3-25-013, D3-25-016, D3-25-017, D3-25-018, D3-25-026, D3-25-027, D3-25-029, D3-25-030, D3-25-034, D3-25-036, D3-25-037, D3-26-001, D3-26-002, D3-26-007\n\n## Distribution\nWorldwide - US Nationwide distribution."}