FDAClass IMay 16, 2018

Fabius MRI recall

Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and…

Why was Fabius MRI recalled?

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.

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?

Serial no: ASKM-0020 ASKM-0011 ASKL-0005 ASKL-0007 ASKL-0010 ASKM-0031 ASKM-0032 ASKM-0023

Product
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and…
Recalling firm
Draeger Medical, Inc.
Quantity
8
Distribution
US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
Recall date
May 16, 2018
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls