Z-2478-2010

Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969...

Name: Z-2478-2010 Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969...
Creator: Draeger Medical Systems, Inc.
Published: 2010-08-26
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2010-08-26 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical Systems, Inc. began a recall of Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 inhalation anesthesia machine for use in operating... on 2010-08-26. The reason FDA records is "potential failures to Electri-Cord Manufacturing AC power cord". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2478-2010
Status: Terminated
Initiated: 2010-08-26
Posted: 2010-09-23
Terminated: 2011-08-23
Recalling firm: Draeger Medical Systems, Inc.
Product: Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 inhalation anesthesia machine for use in operating, induction and recovery rooms
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: potential failures to Electri-Cord Manufacturing AC power cord
Root cause tag: manufacturing process
FDA root cause: Other
Action: Draeger Medical, Inc., sent an Urgent - Medical Device Recall letter dated August 2010 to all customers. The letter described the product, the problem, and actions to be taken by the customer. Customers were instructed to: 1) Immediately take the cord out of service if the plug has bent or cracked prongs, burned plastic, or shows signs of excessive wear. 2) Monitor the affected cords regularly and be mindful of excessive wear and tear, misuse, or abuse until the affected cord is replaced. 3) Customers were also asked to complete and return the enclosed Customer Power Cord Form via mail: Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969; fax: 1-215-721-5808; or e-mail: [email protected]. 4) Disable the cords by cutting off the plug and dispose of the cord in accordance with their facility's disposal procedure when affected power cords are removed. NOTE: The firm will send replacement power cords free of charge. Draeger will only replace power cords originally provided by Draeger (identified with the white flag/part number 4117266. If you have any questions regarding this letter please call 1-800-543-5047 (press 1 at the first prompt, 2 at the second prompt and then 32349#).
Quantity in commerce: up to 1973 products (GS & Tiro)
Distribution: Worldwide Distribution: USA and countries of Brazil, Canada, Columbia, Costa Rica, Cuba, Ecuador, Japan, Lebanon, Nicaragua, Mexico, Panama, Philippines, Saudi Arabia, Taiwan, and Venezuela
Product codes and lots: catalog #8604699

Product code BSZ

K042419Class IIFabius Gs/fabius Tiro Anesthesia SystemDraeger Medical, Inc. / cleared 2004-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)