FDAClass IMay 16, 2018

Fabius GS Premium recall

Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating…

Why was Fabius GS Premium 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: ASKF-0224 ASKF-0232 ASKH-0004 ASKH-0007 ASKH-0038 ASKH-0088 ASKH-0132 ASKH-0133 ASKJ-0007 ASKJ-0178 ASKJ-0179 ASKJ-0184 ASKJ-0205 ASKJ-0220 ASKJ-0224 ASKK-0002 ASKK-0006 ASKK-0010 ASKK-0011 ASKK-0014 ASKK-0019 ASKK-0022 ASKK-0023 ASKK-0032 ASKK-0036 ASKK-0038 ASKK-0044

Product
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating…
Recalling firm
Draeger Medical, Inc.
Quantity
27
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