GE Healthcare Recalls CARESCAPE Monitor B850 for Alarm Priority Issue
GE Healthcare is recalling 636 CARESCAPE Monitor B850 units due to a software issue that may cause incorrect alarm priorities when managed via the iCentral network.
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 with a functional defect that could lead to incorrect alarm prioritization, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 636 units of the CARESCAPE Monitor B850. The recall involves 53 units in the United States and 583 units outside the US. The monitors are intended for use in multiple areas within professional healthcare facilities.
The recall is due to a software issue that occurs when the CARESCAPE Monitor B850 is used with the iCentral network. The issue is specific to configurations where the iCentral has the alarm management software license (L-NETM-00) and the alarm limit change option enabled. When Heart Rate (HR), SpO2, or Invasive pressure alarm limits are changed from the iCentral over the network, the alarm priority on the monitor may be affected.
The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. Users should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
Distribution
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