Draeger Medical Systems Recalls Delta Patient Monitors Due to Low Oxygen Alarm Failure
Draeger Medical Systems is recalling Delta patient monitors used with Scio gas modules because the 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 risk-of-harm product (patient monitor) where a critical safety alarm may fail, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the High severity criteria for theoretical risk without reported harm.
Plain-English summary
Draeger Medical Systems, Inc. is recalling the Delta patient monitor (Catalog Number: MS18597) when used in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, or Scio Four plus gas modules. The recall involves 2,156 units distributed worldwide, including in the United States and numerous international countries. These devices are intended for use by healthcare professionals in patient care environments for adult, pediatric, and neonatal populations.
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 providers from receiving an audible alert when a patient's oxygen levels drop to unsafe levels.
Healthcare facilities and users should stop using the affected devices and contact Draeger Medical Systems for instructions on repair or replacement. The devices are intended to be used in environments where patient care is provided by physicians, nurses, and technicians who determine the indication for use based on professional assessment.
The recalled product
- Product
- Delta, Catalog Number: MS18597 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, a
- 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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