Anesthesia machine recall in Canada: Sensor malfunction may cause patient injury
In plain language
This recall involves several models of anesthesia machines manufactured by Datex-Ohmeda and GE Healthcare. They are being recalled because a sensor malfunction could lead to incorrect anesthesia delivery to patients. Healthcare professionals should stop using affected products and follow the return instructions.
What to do
- Stop using the affected anesthesia machines immediately.
- Contact Datex-Ohmeda or GE Healthcare for specific instructions.
- Return or repair the product as instructed by the manufacturer.
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Affected products
AISYS CARESTATION ANESTHESIA SYSTEM - MAIN UNIT
Model: 1011-9000-000
Lot: More than 10 numbers, contact manufacturer
S/5 AESPIRE 7900 SMARTVENT ANESTHESIA SYSTEM - MAIN UNIT
Model: 1009-9012-000
Lot: More than 10 numbers, contact manufacturer
AESTIVA/5 MRI SYSTEM
Model: 1006-9310-000
Lot: More than 10 numbers, contact manufacturer
S/5 AESPIRE ANESTHESIA MACHINE
Model: 1009-9000-000
Lot: More than 10 numbers, contact manufacturer.
AESTIVA/5 ANAESTHESIA MACHINE
Model: 1006-9305-000 1006-9321-000
Lot: More than 10 numbers, contact manufacturer
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
Model: 1009-9002-000
Lot: More than 10 numbers, contact manufacturer
AESPIRE VIEW - ANESTHESIA MACHINE
Model: 1009-9212-000
Lot: More than 10 numbers, contact manufacturer
AVANCE CS2 - MAIN UNIT
Model: 1009-9050-000
Lot: More than 10 numbers, contact manufacturer
AISYS CS2 ANESTHESIA MACHINE MAIN UNIT
Model: 1011-9050-000
Lot: More than 10 numbers, contact manufacturer
Why this matters
Patient injury due to incorrect anesthesia delivery
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 1006-9305-000 1006-9321-000, 1006-9310-000, 1009-9000-000, 1009-9002-000, 1009-9012-000, 1009-9050-000, 1009-9212-000, 1011-9000-000, 1011-9050-000
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Patient injury due to incorrect anesthesia delivery
What should consumers do?
Stop using the affected anesthesia machines immediately. Contact Datex-Ohmeda or GE Healthcare for specific instructions. Return or repair the product as instructed by the manufacturer.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Patient injury due to incorrect anesthesia delivery
When was this product recalled?
This product was recalled on September 10, 2021.