GE Healthcare Recalls B20i Patient Monitors Due to Network Overload Restart Risk
GE Healthcare is recalling 6,458 B20i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.
What this means for you
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 high-risk medical device where a malfunction (unexpected restart) poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 6,458 B20i and B20i V2 patient monitors. These portable multiparameter units are used in hospital environments and during intra-hospital transport to monitor and record physiological parameters for adult, pediatric, and neonatal patients.
The recall was initiated because the monitors may restart due to network overload caused by network configuration. This issue affects devices distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international markets.
Hospitals and healthcare facilities should contact GE Healthcare for instructions on how to address the network configuration issue. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and dur
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 6,458
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)
- All monitors
Distribution
Part of a larger recall action
This product is one of 5 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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