Image1 SPIES X-LINK Camera Control Unit — Class II medical device recall Z-2134-2016
Terminated recall by Karl Storz Endoscopy, reported 2016-07-13, distributed in AR, CO, CT, DC, FL, GA, ID, IL…. Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used
| Recall number | Z-2134-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2016-06-20 |
| Classified | 2016-07-06 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-01-05 |
| Distributed | AR, CO, CT, DC, FL, GA, ID, IL, KY, MA, MD, MI, MN, MO, NJ, NM, NY, PA, TN, TX, WI |
| Countries outside the US | AR, AU, BE, BG, CN, DE, FI, GB, IN, IT, JP |
| Model numbers | DC1, TC301, TH115, TH116 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2134-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.