[Recalled] PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 — Software issue may result in a loss of patient monitoring at the Hub and Centra… | FDA 2026-07-20

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from GE Medical Systems Information Technologies Inc

• GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B- — Class II
• Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX. — Class II
• GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system — Class II
• PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 — Class II
• FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 — Class II
• PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.