FDAClass IISeptember 2, 2026

FRU (Field replaceable unit) recall: Software Issue

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

Why was FRU (Field replaceable unit) recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI (GTIN) 00195278679307

Product
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Recalling firm
GE Medical Systems Information Technologies Inc
Quantity
0
Distribution
US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.
Recall date
September 2, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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