Draeger Apollo Anesthesia Machine Recalled for Potential Hypoxic Gas Delivery
Draeger Medical is recalling 72 Apollo Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, posing a risk of death.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that potential adverse outcomes include death of the patient, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Draeger Medical, Inc. is recalling 72 units of the Apollo Anesthesia Machine (Catalog No. 8605310). The recall is due to a potential defect in the S-ORC module. In the event of a fault, the module may fail to prevent the setting of a nitrous oxide (N2O) flow that results in a hypoxic mixture being delivered to the patient.
The affected devices are indicated as continuous flow anesthesia systems used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration. The machines are used in operating, induction, and recovery rooms. The recall covers units distributed to healthcare facilities in 33 states across the United States.
Potential adverse outcomes associated with this defect include death of the patient. Healthcare facilities should stop using the affected units and contact Draeger Medical for further instructions on the recall.
The recalled product
- Product
- Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration…
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 72
Distribution
Part of a larger recall action
This product is one of 5 recalled by Draeger Medical, 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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