Fabius GS Tiro Anesthesia Machine recall
Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms.…
Why was Fabius GS Tiro Anesthesia Machine recalled?
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ASKM-0110 ASKM-0111 ASKM-0196 ASKM-0209 ASKM-0232 ASKM-0244 ASKM-0246 ASKN-0032 ASKN-0033 ASKN-0034 ASKN-0037 ASKN-0041 ASKN-0043 ASKN-0068 ASKN-0093 ASLA-0009 ASLA-0021 ASLA-0023 ASLA-0031 ASLA-0032 ASLA-0123 ASLA-0130 ASLA-0135 ASLA-0136 ASLA-0147 ASLA-0155 ASLA-0158 ASLA-0163 ASLA-0166 ASLA-0170 ASLA-0195
- Product
- Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms.…
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 31
- Distribution
- US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
- Recall date
- June 27, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)