Flow-i Anesthesia System Product Usage: The indication recall
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the…
Why was Flow-i Anesthesia System Product Usage: The indication recalled?
Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.
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?
Model numbers: C20, C30 and C40 (Only Model # C20 for US) Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 400 Serial numbers (2743, 2852, 2854, 2855, 2856, 2858
- Product
- Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the…
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 7 units within US
- Distribution
- US Nationwide in the states of CA, NY, and OR
- Recall date
- March 2, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)