GE Healthcare Recalls CARESCAPE Monitor B650 Patient Monitors
GE Healthcare is recalling 2,813 CARESCAPE Monitor B650 units due to potential issues. No illnesses or injuries have been reported.
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 potential issues that could pose a risk of harm, but the source explicitly states that no illnesses or injuries have been reported, fitting the criteria for a High severity rating.
Plain-English summary
GE Healthcare, LLC is recalling 2,813 units of the CARESCAPE Monitor B650. This multi-parameter patient monitor is intended for use in professional healthcare facilities for adult, pediatric, and neonatal patients. The recall was initiated because the company became aware of potential issues associated with the device.
The affected units were distributed worldwide, including in the United States and numerous international markets. The source text does not specify the exact nature of the potential issues or provide a list of specific serial numbers, although the product information indicates a large number of affected serials.
There have been no reported illnesses or injuries associated with the use of this device. Healthcare facilities should contact GE Healthcare for instructions on how to proceed with the recall.
The recalled product
- Product
- GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 2,813
Distribution
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