GE Medical Systems Recalls Portrait Compute and Core Services Software
GE Medical Systems is recalling 4 units of Portrait Compute and Core Services V1.2 software due to a defect that 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 (medical device software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Medical Systems Information Technologies Inc is recalling 4 units of PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592. The affected software is identified by GTIN 00198953056752 and specific serial numbers: SWT25510001TA, SWT26110010TA, SWT26070001TA, and SWT26120008TA.
The recall is being conducted because a software issue 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 an update, meaning they will not 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 internationally in Australia, the Czech Republic, Finland, Germany, Italy, the Netherlands, Qatar, Saudi Arabia, Switzerland, the United Arab Emirates, and the United Kingdom. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Category
- Medical Device — Software
- Affected units
- 4
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 (5)
- GTIN 00198953056752
- Serial Numbers: SWT25510001TA
- SWT26110010TA
- SWT26070001TA
- SWT26120008TA.
Distribution
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