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
Reported: July 13, 2016 Initiated: June 20, 2016 #Z-2134-2016
Product Description
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
Reason for Recall
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).
Details
- Recalling Firm
- Karl Storz Endoscopy
- Units Affected
- 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.
- Location
- El Segundo, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Karl Storz Endoscopy. Units affected: 619 units total (90 units in US).
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2016. Severity: Moderate. Recall number: Z-2134-2016.
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