GE Healthcare Recalls Carescape Patient Data Module Software
GE Healthcare is recalling Carescape Patient Data Module units with v2.0 software due to two issues that may impact patient care.
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 where the software issues 'may impact patient care,' representing a risk-of-harm product where specific injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling approximately 10,250 units of the Carescape Patient Data Module (PDM) equipped with Version 2.0 software. The PDM is intended to provide physiologic parameter data for adult, pediatric, and neonatal patients during bedside and transport care episodes. The affected modules are used with Solar 8000M/l, Transport Pro, or Carescape B650/B850 host monitors.
The recall was initiated because GE Healthcare became aware of two issues with the Version 2.0 software that may impact patient care. The source text does not specify the nature of these issues or report any specific injuries or illnesses.
The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities should contact GE Healthcare for further instructions on how to address the software issues.
The recalled product
- Product
- GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 10,250
Distribution
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