Datex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
Datex-Ohmeda is recalling Aisys anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.
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 defect that interrupts anesthetic delivery, posing a risk of harm to patients if not managed by clinicians, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Datex-Ohmeda, Inc. is recalling 475 units of Aisys anesthesia systems (Part Number 1011-9050-000) distributed worldwide and across the United States. The recall is due to a defect in certain electronic gas mixer assemblies that can cause the system to automatically transition to Alternate O2 control.
When this transition occurs, the system delivers 100% oxygen to the breathing system and initiates audible and visual alarms. This process interrupts the delivery of anesthetic agents, requiring immediate clinician intervention to manage the patient's anesthesia. If intervention is not provided, the patient may experience a decreased anesthetic agent effect.
Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice and contact Datex-Ohmeda for instructions on corrective actions.
The recalled product
- Product
- Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
- Manufacturer
- Datex-Ohmeda, Inc.
- Affected units
- 475
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)
- UDI-DI: 00840682102292
Distribution
Distributed nationwide across the United States.
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