Z-3039-2026Class II

FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225

Name: Z-3039-2026 FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Creator: GE Medical Systems Information Technologies Inc
Published: 2026-07-20
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2026-07-20 / Open, Classified / root cause: design

FDA source

GE Medical Systems Information Technologies Inc began a recall of FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 on 2026-07-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3039-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-20
Posted: 2026-08-27
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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.
Root cause tag: design
FDA 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 alternative monitoring. Please place a copy of the addendum in Appendix A with the User Manual for your Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2 system in your facility. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 0
Distribution: US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Product codes and lots: UDI-DI (GTIN) 00195278679307

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3039-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3036-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-27
Z-3037-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-27
Z-3038-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-27
Z-3039-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-27

Product code MWI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)