Portrait Core Services Software Loss of Patient Monitoring After 425 Days
A software issue in GE's Portrait Core Services medical device software causes loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous operation.
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: This is an FDA Class II recall involving a software defect that results in loss of patient monitoring capability. No illnesses or injuries have been reported. The hazard represents a risk-of-harm to patients but without documented incidents, placing it in the High severity category per the rubric.
Plain-English summary
Portrait Core Services is software that enables communication and integration of Portrait Mobile Monitoring Solution components within healthcare facility infrastructure and clinical information systems. A software defect can cause loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous run-time.
Seven systems are affected and are distributed worldwide, including in the United States (Ohio and Texas), and internationally in Australia, China, Czech Republic, France, Italy, Netherlands, Qatar, Singapore, United Arab Emirates, and United Kingdom.
The affected equipment has been identified by manufacturer GE Medical Systems, LLC with specific serial numbers and identifiers for tracking and follow-up.
The recalled product
- Product
- Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 7
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: 00195278659446
Distribution
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