Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial no: ASKJ-0195 ASKK-0079 ASKF-0226 ASKF-0227 ASKF-0228 ASKF-0229 ASKF-0230 ASKH-0086 ASKH-0071 ASKJ-0177 ASKK-0020 ASKK-0021 ASKH-0053 ASKH-0054 ASKH-0055 ASKH-0056 ASKH-0057 ASKH-0067 ASKH-0068 ASKH-0063 ASKH-0065 ASKH-0064 ASKH-0130 ASKH-0131 ASKJ-0173 ASKH-0031
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Draeger Medical, Inc.
- Reason for Recall:
- The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
Product Codes/Lot Numbers:
Serial no: ASKJ-0195 ASKK-0079 ASKF-0226 ASKF-0227 ASKF-0228 ASKF-0229 ASKF-0230 ASKH-0086 ASKH-0071 ASKJ-0177 ASKK-0020 ASKK-0021 ASKH-0053 ASKH-0054 ASKH-0055 ASKH-0056 ASKH-0057 ASKH-0067 ASKH-0068 ASKH-0063 ASKH-0065 ASKH-0064 ASKH-0130 ASKH-0131 ASKJ-0173 ASKH-0031
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1483-2018
Related Recalls
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Draeger Medical
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.