Company:Maquet Medical Systems USA
Date of Enforcement Report 6/18/12
Date Recall Initiated: February 20, 2012
Class l:
PRODUCT
FLOW-i Anesthesia System (software)
REASON
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.
RECALLING FIRM/MANUFACTURER
Maquet Medical Systems USA, Wayne, New Jersey
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.
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