{"url_path":"/fda/device/recalls/Z-2553-2026","section_key":"summary","section_title":"DEVICE Recall: GE Medical Systems SCS — GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-08","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2553-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"GE Medical Systems SCS"},"word_count":214,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2553-2026\n\n**Recalling firm:** GE Medical Systems SCS\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-08\n**Report date:** 2026-07-01\n\n## Product\nGE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System\n\n## Reason\nGE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one.  When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.\n\n## Affected lots\nREF# (01)00840682102384(10)AWS03D02E6D5, GTIN Number 00840682102384\n\n## Distribution\nWorldwide distribution - United States Nationwide and the countries of Algeria, Australia, Belarus, Belgium, Benin, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Morocco, Nepal, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, United Arab Emirates, United Kingdom, Vietnam."}