Recall Z-2134-2016 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Karl Storz Endoscopy
Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
| Date | Jul 6, 2016 (initiated Jun 20, 2016) |
| Status | Terminated |
| Reason | Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG). |
| Root cause | Device Design |
| Action | KARL STORZ sent an Customer Notification letter dated June 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. KARL STORZ has become aware become aware of a potential electrical interference issue when the lmage1 SPIES X-LINK and lmage1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinoscope and an electro-surgery generator (ESG). Customers are instructed to complete the attached acknowledgement Form and to return it to KARL STORZ. Customers with questions are instructed to contact Te |
| Quantity | 619 units total (90 units in US) |
| Distribution | Worldwide Distribution - US Distribution to the states of : IL, NM, TX, MD, TN, PA, FL, KY, MO, NY, MN, DC, MA, WI, CT, MI, ID, CO, GA, NJ and AR., and to the countries of : Argentina, Australia, Belgium, Bulgaria, China, Germany, Finland, Great Britain, India, Italy and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131953 | IMAGE1 SPIES KARL STORZ Endoscopy-America, Inc., Dec 20, 2013 |