FDA Closes Class II Recall of GE HealthCare Patient Monitoring Software
The FDA has terminated recall Z-3037-2026 for PORTRAIT COMPUTE AND CORE SERVICES V1.2, saying the action is complete.
2 reports on this incident · first at Sep 9, 2026, 8:42 p.m. ET
Earlier reports
Sep 9, 2026, 8:42 p.m. ETFirst report
FDA Class II Recall of GE HealthCare Patient Monitoring Software
The FDA has classified a recall of PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592, as Class II, according to the agency's enforcement report for recall number Z-3037-2026. The recall was initiated on July 20, 2026, and reported on September 2, 2026. The product is manufactured by GE Medical Systems Information Technologies Inc in Waukesha, Wisconsin.
The FDA's enforcement report states that a 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. The recall covers 4 units, identified by GTIN 00198953056752 and serial numbers SWT25510001TA, SWT26110010TA, SWT26070001TA, and SWT26120008TA.
According to the FDA's definitions, Class II is the agency's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The recall is ongoing and has been distributed to locations in the US (Michigan and New York) and internationally to Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, and United Kingdom.
The FDA's database records no other enforcement action by this firm.
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Revision history
- Version 110 Sept 2026, 00:42current
First published.
- Version 110 Sept 2026, 00:54current
First published.
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