Recall Z-3039-2026— GE Medical Systems Information Technologies Inc
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems Information Technologies Inc, initiated 2026-07-20. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-20
- Firm location
- Waukesha, WI, United States
Product description
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.