Karl Storz Image1 SPIES X-LINK Camera Control Unit Recall
Karl Storz Endoscopy is recalling Image1 SPIES X-LINK Camera Control Units due to potential electrical interference when used with specific camera heads and mediastinoscopes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (electrical interference in a medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Karl Storz Endoscopy is recalling the Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301. This recall applies when the unit is used in conjunction with the Image1 SPIES D1 camera head (Product Model No. TH116 & TH115) and the DC1 Video Mediastinoscope.
The recall is issued due to a potential electrical interference issue that may occur when the affected equipment is used together with an electro-surgery generator (ESG). The source text does not report any specific injuries, illnesses, or deaths associated with this issue.
A total of 619 units were distributed worldwide, with 90 units distributed in the United States. US distribution included 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. International distribution included Argentina, Australia, Belgium, Bulgaria, China, Germany, Finland, Great Britain, India, Italy, and Japan. Users should stop using the affected equipment and contact the manufacturer for instructions.
The recalled product
- Product
- 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
- Manufacturer
- Karl Storz Endoscopy
- Hazard
Distribution
Related recalls
Same manufacturer · Karl Storz Endoscopy
See all →- HighFlexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals
FDA (Devices) · 2026-07-29
- ModerateKarl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2025-02-05
- HighKarl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
FDA (Devices) · 2025-02-05
Same hazard · electrical interference
See all →- HighNovaGuide 2 Ultrasound Systems Recalled for Electrical Shock Risk
FDA (Devices) · 2024-07-03
- HighNovaGuide 2 Ultrasound System Recall Due to Grounding Cable Disconnection Risk
FDA (Devices) · 2024-07-03
- HighPhilips Tempus LS-Manual Defibrillator may malfunction from electrical interference
FDA (Devices) · 2024-06-12
- SevereCereLink ICP Monitor recalled for out-of-range pressure readings
FDA (Devices) · 2022-08-03
- HighStryker S-Series Equipment Management System Recall for Brake Disengagement Risk
FDA (Devices) · 2021-03-31