Z-2134-2016Class II

Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera...

Name: Z-2134-2016 Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera...
Creator: Karl Storz Endoscopy
Published: 2016-06-20
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2016-06-20 / Terminated / root cause: design

FDA source

Karl Storz Endoscopy began a recall of 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... on 2016-06-20. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2134-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-20
Posted: 2016-07-06
Terminated: 2017-01-05
Recalling firm: Karl Storz Endoscopy-America, Inc.
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
Product code: FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
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).
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: NT743473-P NT743472-P NT742840-P XU738911-P YU741045-P XU738248-P WU737260-P PV715203-P PV715207-P NT742829-P XU738899-P WU737275-P YV724235-P WU737269-P WU737268-P VU736411-P XU738901-P XU738910-P ZU742677-P YU741050-P VU736405-P TU733422-P TU733419-P SU733063-P VU736390-P VU736386-P UU734392-P RV716122-P OT744400-P NT743287-P OT744395-P NU727551-P NU727552-P NU727706-P TU734218-P TU734217-P NT742846-P YU741046-P OU728667-P TU733735-P VU736388-P NT742848-P NT742838-P OU728672-P OU728427-P WU737813-P OU729135-P OU728431-P OU728430-P WU737805-P ZU742670-P ZU742671-P YU741049-P YU740475-P ZU742681-P RV716116-P SU733055-P SU733057-P SU733059-P SU733060-P TU733418-P TU733420-P TU733421-P TU733423-P TU733424-P TU733425-P TU733427-P WU737810-P XU738914-P YU740004-P YU740471-P YU740479-P YU740480-P YU741036-P NV711744-P PV715216-P OU728670-P NU726430-P OT744399-P OT744389-P OT744386-P YU739999-P YU740003-P YU740005-P UU734395-P YV724443-P YV724442-P YV724440-P YV724438-P YV724245-P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2134-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2134-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

Product code FET

K131953Class IIImage1 SpiesKARL STORZ Endoscopy-America, Inc. / cleared 2013-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)