Draegar Delta XL Patient Monitors Recalled for Low Oxygen Alarm Failure
Draegar Medical Systems is recalling Delta XL patient monitors because the low oxygen alarm may fail to sound when oxygen levels drop below the limit.
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 is classified as FDA Class II, and the hazard involves a critical safety alarm failure (low O2) that could lead to significant patient harm or injury if undetected.
Plain-English summary
Draegar Medical Systems, Inc. is recalling Delta XL patient monitors (Catalog Number MS18596) in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, and Scio Four plus gas modules. The recall involves 2,156 units distributed worldwide, including in the United States and numerous international markets.
The recall was initiated because it was reported that the set low O2 alarm does not go off even when the measured O2 level is below the alarm limit. This failure could prevent healthcare professionals from receiving an audible or visual alert when a patient's oxygen levels drop to unsafe levels.
These devices are intended for use by healthcare professionals, including physicians, nurses, and technicians, in environments where patient care is provided. The monitors are used on adult, pediatric, and neonatal populations to track various physiological parameters. Healthcare facilities should contact Draegar Medical Systems for instructions on how to address the alarm defect.
The recalled product
- Product
- Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses,
- 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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