Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Prod
FDA device recall Z-2134-2016 · posted 2016-07-06 · Terminated
Recall details
- Recalling firm
- Karl Storz Endoscopy
- 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).
- Action taken
- KARL STORZ sent an Customer Notification letter dated June 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. KARL STORZ has become aware become aware of a potential electrical interference issue when the lmage1 SPIES X-LINK and lmage1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinoscope and an electro-surgery generator (ESG). Customers are instructed to complete the attached acknowledgement Form and to return it to KARL STORZ. Customers with questions are instructed to contact Technical Support Dept. at (800) 421-0837, press 2, and then press 1.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FET
- Quantity 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, Belg
- Date initiated
- 2016-06-20
- Date posted
- 2016-07-06
- Date terminated
- 2017-01-05
- Location
- El Segundo, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMAGE1 SPIES (K131953) | KARL STORZ Endoscopy-America, Inc. | 2013-12-20 |