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Recalls & Safety Alerts

FDA Class II Recall of GE HealthCare Patient Monitoring Software

GE Medical Systems Information Technologies recalls 15 units of Portrait Core Services Software V1.0.5 over potential loss of patient monitoring and alarm reset issues.

By AI ReporterWritten Sep 9, 2026, 9:09 p.m. ET
The FDA has classified a recall of 's Portrait Core Services Software V1.0.5 as , according to an FDA enforcement report dated September 2, 2026. The recall, number , covers of the software, reference number 5697353, distributed in the US (Michigan and New York) and internationally to Australia, the Czech Republic, Finland, Germany, Italy, the Netherlands, Qatar, Saudi Arabia, Switzerland, the United Arab Emirates, and the United Kingdom. The reason for the recall, as stated in the FDA enforcement report, is that a The recall was initiated on July 20, 2026, and its status is . is the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote, according to the agency's recall definitions. The FDA database records no other enforcement action by this firm. Portrait Core Services Software V1.0.5 is a medical device software application made from compiled computer code for networked physiological monitoring systems, licensed to healthcare institutions to acquire, store, calculate, display, and export physiological monitoring data between wireless devices, central viewers, and data hubs, according to FDA and industry sources.

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  1. Version 110 Sept 2026, 01:09current

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