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Terminated

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.

FDA Recall Z-1925-2012 · Posted 2012-07-06

Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeBSZ
Date Initiated2012-02-20
Date Terminated2015-09-09
Product Quantity284 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112114MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40Maquet Critical Care AB · 2012-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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