Datex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
Datex-Ohmeda is recalling seven Aisys CS2 anesthesia systems because a gas mixer defect can interrupt anesthetic delivery, requiring clinician intervention to prevent decreased patient effect.
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 3/5 (High).
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 addressed, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Datex-Ohmeda, Inc. is recalling seven units of the Aisys CS2 with Et Control anesthesia system (Part Number 1011-9000-000). The recall involves specific serial numbers: ANAS01357, ANAP00609, ANAQ00988, ANAS00586, ANAR00543, ANAP01088, and ANAM00443. The affected products were distributed worldwide and nationwide in 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. In this mode, the system delivers 100% oxygen to the breathing system and initiates audible and visual alarms. This transition interrupts the delivery of the anesthetic agent, requiring immediate clinician intervention. If intervention is not provided, the patient may experience a decreased anesthetic agent effect.
Healthcare facilities and users should check their inventory for the specific serial numbers listed above. If a unit is affected, it should be removed from service and returned to Datex-Ohmeda, Inc. for evaluation and repair or replacement.
The recalled product
- Product
- Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
- Manufacturer
- Datex-Ohmeda, Inc.
- Affected units
- 7
Distribution
Distributed nationwide across the United States.
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