Z-1925-2012Class I

FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the...

Name: Z-1925-2012 FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2012-02-20
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2012-02-20 / Terminated / root cause: design

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to... on 2012-02-20. FDA classified it as Class I and gives the reason as "A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1925-2012
Classification: Class I
Status: Terminated
Initiated: 2012-02-20
Posted: 2012-07-06
Terminated: 2015-09-09
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Maquet Getinge Group, sent an "URGENT DEVICE FIELD CORRECTION" letter dated February 20, 2012 to its customers. The letter describes the product, problem and action to be taken. The letter state that a Maquet Service Representative will upgrade the customers software in the FLOW-i Anesthesia System to the current revision and also provide the customers with the corresponding user's manual. Note: This upgrade includes other minor improvements. The customers were instructed to sign a document to verify satisfactory completion of the work once the software upgrade was completed. If you have questions or require additional information, please contact your local MAQUET representative or Technical Support at 888-627-8383. A press release was issued on 7/6/2012.
Quantity in commerce: 284 units
Distribution: Worldwide distribution: USA (nationwide) state of GA only and countries of: Argentina, Australia, Austria, Belgium, China, Czech Republic, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Spain, Sweden incl Maquet Critical Care, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
Product codes and lots: Model Number :6677300 Serial Number : 1170

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1925-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1925-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06

Product code BSZ

K112114Class IIMaquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB / cleared 2012-01-13

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)