Ge Medical Systems Information Technologies Inc: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Product
- FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-20
- Status
- Open, Classified
- Areas affected
- MI, NY
- Distribution
- US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ee1a33d3-77db-4698-b48f-78ad2a2fadb9