Fabian™ HFO Ventilator recall in Canada: Inadequate ventilation risk
In plain language
This recall involves Fabian™ HFO Ventilators sold in Canada. It's being recalled because a software issue could lead to inadequate ventilation. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer for additional information.
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Affected products
Fabian™ HFO Ventilator
Model: 112001, 113001
Lot: All lots.
Why this matters
Inadequate ventilation due to oscillation being out of range, resulting in hypoxia, hypercapnia, hypoventilation and/or respiratory arrest.
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: All lots.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 112001, 113001
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?
Inadequate ventilation due to oscillation being out of range, resulting in hypoxia, hypercapnia, hypoventilation and/or respiratory arrest.
What should consumers do?
Contact the manufacturer for additional information.
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. Inadequate ventilation due to oscillation being out of range, resulting in hypoxia, hypercapnia, hypoventilation and/or respiratory arrest.
When was this product recalled?
This product was recalled on May 24, 2024.
Is the Acutronic Medical Systems Ag brand affected by this recall?
Yes, Acutronic Medical Systems Ag products are affected by this recall. This recall involves Fabian™ HFO Ventilators sold in Canada. It's being recalled because a software issue could lead to inadequate ventilation. Healthcare professionals should contact the manufacturer for more information.