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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Portrait

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 Class 2 Device Recall GE Healthcare Portraitsee related information
Date Initiated by FirmJuly 20, 2026
Date PostedAugust 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3036-2026
Recall Event ID 99536
510(K)NumberK234130 
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
ProductPORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Code Information GTIN 00195278679284, Serial Numbers: SWT25250001TA, SWT25360001TA, SWT25360002TA, SWT24090006TA, SWT25100001TA, SWT25120002TA, SWT24140007TA, SWT24150008TA, SWT25100004TA, SWT24050001TA, SWT25110003TA, SWT24180011TA, SWT25120003TA, SWT25230001TA, SWT25230002TA, SWT25110009TA, SWT25110010TA, SWT25230003TA, SWT25230005TA, SWT25230006TA, SWT25230004TA, SWT25260001TA, SWT31240012TA.
FEI Number 3001570235
Recalling Firm/
Manufacturer		 GE Medical Systems Information Technologies Inc
3114 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionGE 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 Commerce23 units
DistributionUS: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MWI
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