GE CARESCAPE Central Station audio alarms may be muted with unapproved keyboard
GE Healthcare is recalling 10,445 CARESCAPE Central Station monitoring systems. If connected to an unapproved keyboard, audio alarms may be muted, potentially preventing users from receiving critical notifications.
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: FDA Class II recall involving potential loss of audible alarms on a medical monitoring device. The hazard is contingent on use of an unapproved keyboard and no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
GE Healthcare is recalling 10,445 units of the CARESCAPE Central Station v2.0 (models MAI700 Integrated and MAS700 Desktop). The recall addresses a configuration issue where use of an unapproved keyboard can result in the audio alarms being muted. Loss of audible alarms could prevent users from receiving critical notifications.
The affected devices were distributed worldwide, including throughout the United States, Puerto Rico, and more than 50 countries. Specific affected units have serial numbers beginning with SKN or SNF (MAI700 models) or SNF (MAS700 model), running software version 2.0.x (versions 2.0.0, 2.0.1, 2.0.2, or 2.0.3).
Facilities and organizations currently using these CARESCAPE Central Station systems should verify they are using only approved keyboards with their equipment. Users with questions should contact GE Healthcare directly.
The recalled product
- Product
- GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- audible-alarm-loss
- unapproved-keyboard
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 (7)
- Version 2.0.x (v2.0.0
- v2.0.1
- v2.0.2
- or v2.0.3) with serial numbers beginning with SKN for the MAI700 Integrated
- UDI 0100840682109604
- or serial numbers beginning with SNF for the MAS700 Desktop
- UDI 00840682109604.
Distribution
Distributed nationwide across the United States.
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