Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 72201919 The 560P camera system is configured to be connected as a stand-alone system on an endoscopic cart or tower. It is designed for use with the Smith & Nephew 560H 3-CCD High Definition Camera Head (560H camera head). The 560P camera system is designed to be used in conjunction with various peripheral devices, including the 560H camera head, Smith & Nephews 300 watt xenon light source, various flat panel displays, image capture devices, and print and video recording devices.
FDA Recall Z-1479-2012 · Posted 2012-05-01
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Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeGCJ
Date Initiated2012-03-29
Date Terminated2016-01-13
Product Quantity239 units
Reason for Recall
May experience intermittent loss of video
due to a defective board component
Firm Action
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
Distribution Pattern
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-pacific: Australia, China, Hong Kong, India, Japan, Singapore, South Korea, and Thailand, Mexico, Puerto Rico, South Africa, Turkey, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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