Datex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
Datex-Ohmeda is recalling 410 Et Control software units for anesthesia gas machines that may 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 with a risk of harm (decreased anesthetic effect) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Datex-Ohmeda, Inc. is recalling 410 units of Et Control, a software option for anesthesia gas machines, due to a defect in certain electronic gas mixer assemblies. The affected units are distributed worldwide and across the United States.
The recall is issued because the systems can automatically transition to Alternate O2 control, a mode that delivers 100% oxygen to the breathing system. When this transition occurs, the delivery of anesthetic agents is interrupted, and the system initiates audible and visual alarms. This interruption requires immediate clinician intervention to manage the patient's ventilation and anesthetic levels.
If clinician intervention is not provided promptly, patients may experience a decreased effect of the anesthetic agent. Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice and contact the manufacturer for instructions on remediation.
The recalled product
- Product
- Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665
- Manufacturer
- Datex-Ohmeda, Inc.
- Affected units
- 410
Distribution
Distributed nationwide across the United States.
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