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Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 72201919 The 560P camera system is configured to

FDA device recall Z-1479-2012 · posted 2012-05-01 · Terminated

Recall details

Recalling firm
Smith & Nephew, Inc. Endoscopy Division
Reason for recall
May experience intermittent loss of video due to a defective board component
Action taken
Smith & Nephew Endoscopy Division sent an "URGENT PRODUCT RECALL 1st NOTIFICATION" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and to complete and return the bottom portion of the letter via fax at 405-917-8650. Contact the firm at 405-917-8556 for questions regarding this notice.
Root cause
Nonconforming Material/Component
Status
Terminated
Product code
GCJ
Quantity affected
239 units
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and UK Asia-
Date initiated
2012-03-29
Date posted
2012-05-01
Date terminated
2016-01-13
Location
Andover, MA

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Related 510(k) clearances

RecordFirmDate
560 HIGH DEFINITION CAMERA SYSTEM (K070266)Smith & Nephew, Inc.2007-02-22