Draeger Perseus A500 Anesthesia Machine Recalled for Hypoxic Mixture Risk
Draeger Medical is recalling 33 Perseus A500 anesthesia machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that potential adverse outcomes include death of the patient, which meets the criteria for a Severe (Score 4) classification involving significant injury or death reports.
Plain-English summary
Draeger Medical, Inc. is recalling 33 units of the Perseus A500 Anesthesia Machine (Catalog No. MK06000). The recall affects units distributed to healthcare facilities in 33 states across the United States, including Alaska, California, Florida, New York, and Texas.
The recall is due to a potential fault in the S-ORC module. If this fault occurs, the module may fail to prevent the setting of a nitrous oxide (N2O) flow that results in a hypoxic gas mixture being delivered to the patient. The source text states that potential adverse outcomes include death of the patient.
Healthcare facilities should identify affected units by checking the specific serial numbers listed in the recall notice. Draeger Medical is the recalling firm and is responsible for managing the recall process for these devices.
The recalled product
- Product
- Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is…
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- Affected units
- 33
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.
See all 5 products in this recall →Related recalls
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