Recall Z-1479-2012 ยท GCJ Laparoscope, General & Plastic Surgery
Smith & Nephew, Inc. Endoscopy Division
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
| Date | May 1, 2012 (initiated Mar 29, 2012) |
| Status | Terminated |
| Reason | May experience intermittent loss of video due to a defective board component |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 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-pacific: Australia, China, Hong Kong, India, Japan, Singapore, South Korea, and Thailand, Mexico, Pu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070266 | 560 HIGH DEFINITION CAMERA SYSTEM Smith & Nephew, Inc., Feb 22, 2007 |