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

FDA device recall Z-1925-2012 · posted 2012-07-06 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

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.

Action taken

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

Status

Terminated

Product code

BSZ

Quantity affected

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, It

Date initiated

2012-02-20

Date posted

2012-07-06

Date terminated

2015-09-09

Location

Wayne, NJ

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