Draegar Medical Systems Recalls Kappa and Scio Patient Monitors
Draegar Medical Systems is recalling Kappa and Scio patient monitors because a low oxygen alarm may fail to sound when oxygen levels drop below the set limit.
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 medical device where a safety alarm may fail to sound, posing 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 without reported injury.
Plain-English summary
Draegar Medical Systems, Inc. is recalling Kappa (Catalog Number MS18853) in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, and Scio Four plus monitors (Catalog Numbers MS18597/MS18596/MS18853). The recall involves 2,156 units distributed worldwide, including in the United States and numerous international countries.
The recall was initiated because it was reported that the low oxygen (O2) alarm does not activate even when the measured oxygen level falls below the alarm limit. These devices are intended for use by healthcare professionals to monitor patient conditions, including gas content in breathing gases.
Healthcare facilities should contact Draegar Medical Systems for instructions on how to address the defect. The source text does not specify a specific action for consumers, as these are professional medical devices.
The recalled product
- Product
- Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthca
- Manufacturer
- Draegar Medical Systems, Inc.
- Category
- Medical Device — Patient Monitor
- Affected units
- 2,156
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)
- VF10.0 software
Distribution
Part of a larger recall action
This product is one of 3 recalled by Draegar Medical Systems, Inc. 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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