Recall Z-3039-2026 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
GE Medical Systems Information Technologies Inc
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
| Date | Aug 27, 2026 (initiated Jul 20, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 7/20/2026 by letter delivered using traceable means. The notice explained the issue, potential risk, and requested the following: "Actions to be taken by Customer/User You can continue to use your Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2. Please ensure appropriate alternative monitoring is established for patients before a software update is started. A User Manual addendum is included with this letter that includes specific instructions related to alterna |
| Quantity | 0 |
| Distribution | US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.