Recall Z-3038-2026— GE Medical Systems Information Technologies Inc

Name: FDA recall Z-3038-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-20

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems Information Technologies Inc, initiated 2026-07-20. It names one FDA 510(k) clearance: K230626. Product: PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353. 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

510(k) clearances named in this recall

1 on FDA's record

K230626 — Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01) +3 moreGe Medical Systems Information Technologies, Inc.·cleared 2023-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353

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.