Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 8

FDA device recall Z-3092-2011 · posted 2011-08-30 · Terminated

Recall details

Recalling firm

Covidien, PLC

Reason for recall

Generator may deliver full power when a lower power is selected.

Action taken

Covidien sales reps began notifying affected customers on February 6, 2009, followed by a letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the affected product to: Covidien Energy Based Devices 5920 Longbow Road Boulder, Colorado 80301 Customers were asked to label the exterior of the carton with their Return Authorization number. Covidien EbD would address the issue and return the unit to them. For any questions customers were asked to call Covidien EbD's Service Department toll-free at 1-800-255-8522, x 4923 or contact their local sales representative for additional information.

Root cause

Component design/selection

Status

Terminated

Product code

GEI

Quantity affected

357 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, Spain,

Date initiated

2009-02-06

Date posted

2011-08-30

Date terminated

2011-08-30

Location

Boulder, CO

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