GE Medical Systems Recalls Portrait Core Services Software Reload Unit
GE Medical Systems is recalling a software reload unit for the Portrait Core Services system due to a defect that may cause loss of patient monitoring and reset alarm settings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that may result in a loss of patient monitoring and reset alarm settings, which poses a risk of harm to patients. No specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
GE Medical Systems Information Technologies Inc is recalling the FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225. The recall is due to a software issue that may result in a loss of patient monitoring at the Hub and Central Viewer. Additionally, all alarm settings could be reset to factory defaults following the update, failing to follow the alarm settings previously configured for each patient or care area.
The affected units were distributed in the United States (Michigan and New York) and in Australia, the Czech Republic, Finland, Germany, Italy, the Netherlands, Qatar, Saudi Arabia, Switzerland, the United Arab Emirates, and the United Kingdom. The product is identified by UDI-DI (GTIN) 00195278679307.
Healthcare facilities should contact GE Medical Systems Information Technologies Inc for instructions on how to address the software issue and ensure patient monitoring and alarm settings are properly configured.
The recalled product
- Product
- FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
- Manufacturer
- GE Medical Systems Information Technologies Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI (GTIN) 00195278679307
Distribution
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