GE Healthcare Recalls CARESCAPE ONE Monitors Due to Alarm Failure Risk
GE Healthcare is recalling 8,414 CARESCAPE ONE patient monitors because they may fail to provide visual and audible alarms for Ventricular Fibrillation when docked to specific host monitors.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device that may fail to alarm for Ventricular Fibrillation, a life-threatening condition. This represents a significant risk of serious injury or death due to lack of warning, fitting the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
GE Healthcare, LLC is recalling 8,414 units of the CARESCAPE ONE Physiological Patient Monitor. The device is used in professional healthcare facilities for monitoring patients in multiple areas and during intra-hospital transport.
The recall is issued because the CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib) if the condition occurs while the device is docked to a CARESCAPE B450, B650, or B850 host monitor. This failure could prevent healthcare providers from receiving critical alerts regarding a life-threatening heart rhythm.
The affected units were distributed worldwide and across the United States, including in Montana, North Carolina, Texas, and Wisconsin. Healthcare facilities should identify affected units by checking the model number 2087075-001 and the specific serial numbers listed in the official recall notice. Users should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 8,414
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 (20)
- Model: 2087075-001 Serial Numbers: SNA20210164SA
- SNA20210031SA
- SNA20210045SA
- SNA20210064SA
- SNA20210319SA
- SNA20210330SA
- SNA20210348SA
- SNA20210361SA
- SNA20210362SA
- SNA20210375SA
- SNA20210376SA
- SNA20210377SA
- SNA20220003SA
- SNA20220005SA
- SNA20220007SA
- SNA20220018SA
- SNA20220022SA
- SNA20220026SA
- SNA20220045SA
- SNA20220047SA
Distribution
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