Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Image1 SPIES X-LINK Camera Control Unit (CCU) Recalled by Karl Storz Endoscopy Due to Potential electrical interference issue when the Image1 SPIES...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Karl Storz Endoscopy directly.
Affected Products
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
Quantity: 619 units total (90 units in US)
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed to 21 states: AR, CO, CT, FL, GA, ID, IL, KY, MD, MA, MI, MN, MO, NJ, NM, NY, PA, TN, TX, WI, DC
About Karl Storz Endoscopy
Karl Storz Endoscopy has 70 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report