GE Medical Systems Recalls Portrait Core Services Software Due to Monitoring Loss
GE Medical Systems is recalling 15 units of Portrait Core Services Software V1.0.5 because a software issue may cause loss of patient monitoring and reset alarm settings to factory defaults.
What this means for you
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 risk-of-harm product (patient monitoring software) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
GE Medical Systems Information Technologies Inc is recalling 15 units of PORTRAIT CORE SERVICES SOFTWARE V1.0.5 (Ref# 5697353). 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, meaning they will not follow the alarm settings previously configured for each patient or care area.
The affected software was distributed in the United States (Michigan and New York) and internationally in Australia, the Czech Republic, Finland, Germany, Italy, the Netherlands, Qatar, Saudi Arabia, Switzerland, the United Arab Emirates, and the United Kingdom. The recall is classified as Class II by the FDA.
Healthcare facilities using this software should contact GE Medical Systems for further instructions on how to address the monitoring and alarm configuration issues.
The recalled product
- Product
- PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Category
- Medical Device — Software
- Affected units
- 15
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 (16)
- GTIN 00195278364838
- Serial Numbers: SUC23080050TA
- SUD22470001TA
- SUD22420001TA
- SUD22470010TA
- SUD23390001TA
- SUD23390003TA
- SUD23390004TA
- SUD23390009TA
- SUD23390010TA
- SUD22470009TA
- SUD22470003TA
- SUD22470004TA
- SUD22470005TA
- SUD23390005TA
- SUD22280002TA.
Distribution
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