GE Medical Systems Recalls Portrait Core Services Software Due to Monitoring Loss
GE Medical Systems is recalling Portrait Core Services Software V1.1 because a software issue may cause loss of patient monitoring and reset alarm settings to factory defaults.
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 risk-of-harm product (patient monitoring loss) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Medical Systems Information Technologies Inc is recalling 23 units of PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209. 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 in Australia, the Czech Republic, Finland, Germany, Italy, the Netherlands, Qatar, Saudi Arabia, Switzerland, the United Arab Emirates, and the United Kingdom. The agency has classified this recall as Class II.
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 correctly configured.
The recalled product
- Product
- PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Category
- Medical Device — Software
- Affected units
- 23
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 (20)
- GTIN 00195278679284
- Serial Numbers: SWT25250001TA
- SWT25360001TA
- SWT25360002TA
- SWT24090006TA
- SWT25100001TA
- SWT25120002TA
- SWT24140007TA
- SWT24150008TA
- SWT25100004TA
- SWT24050001TA
- SWT25110003TA
- SWT24180011TA
- SWT25120003TA
- SWT25230001TA
- SWT25230002TA
- SWT25110009TA
- SWT25110010TA
- SWT25230003TA
- SWT25230005TA
Distribution
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