PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Summary
The FDA issued a Class II for PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 by GE Medical Systems Information Technologies Inc. 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 def.
Details
Source
Device Recall
External ID
Z-3036-2026
Action Date
2026-09-02
Status
Ongoing
Category
device
Product Description
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Lot/Code Info: 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.
Quantity Affected: 23 units
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.
Distribution
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-20
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 445 device-related FDA actions this month.
GE Medical Systems Information Technologies Inc has 31 FDA actions in our database, including 18 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems Information Technologies Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems Information Technologies Inc have FDA actions?
GE Medical Systems Information Technologies Inc has 31 FDA actions in our database, including 18 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3036-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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