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U.S. Department of Health and Human Services

Medical Devices

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Maquet Medical Systems USA, FLOW-i Anesthesia System (software)

Recall Class: Class I

Date Recall Initiated: February 20, 2012

Product: FLOW-i Anesthesia System (software)

Model: FLOW-i C30, Model Number: 6677300, Serial Number: 1170

The FLOW-i Anesthesia System was distributed from May 9, 2010 through December 29, 2011.

Use: The FLOW-i Anesthesia System is intended to administer anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as supporting patients with a limited ability to breathe.

Recalling Firm:

Maquet Medical Systems USA
45 Barbour Pond Drive
Wayne, New Jersey 07470

Reason for Recall: A technical alarm may be generated on the FLOW-i system when using the Manual/Automatic (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 between the two positions. Use of this product may cause serious adverse health consequences, including death.

Public Contact:
Customers with questions or who require additional information may contact their local MAQUET representative or Technical Support at 1-888-627-8383.

FDA District: New Jersey District Office

FDA Comments:

On February 20, 2012, the firm sent its customers an Urgent Device Field Correction notice. The firm informed their customers that their Maquet Service Representative will upgrade the software in their FLOW-i Anesthesia System to the current version and also provide them with the corresponding user manual. The firm added that the upgrade includes other minor improvements. This work will be done at no cost to the customer or the facility. Upon completion of the software upgrade, the customer will be asked to sign a document to verify that the work was completed satisfactorily.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.