Recall Z-2134-2016— Karl Storz Endoscopy
Class II · Terminated
Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2016-06-20, terminated 2017-01-05. It names one FDA 510(k) clearance: K131953. 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. 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)..
- Recalling firm
- Karl Storz Endoscopy
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-20
- Terminated
- 2017-01-05
- Firm location
- El Segundo, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.