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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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