FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: 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.
- Recall number
- Z-1925-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-02-20
- Posted
- 2012-07-06
- Terminated
- 2015-09-09
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Model Number :6677300 Serial Number : 1170
- 510(k) numbers
- ["K112114"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28