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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74515

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 20, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Karl Storz Endoscopy

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2134-2016
Recall number
Z-2134-2016
Initiated
June 20, 2016
Classification
Class II
Status
Terminated
Recalling firm
Karl Storz Endoscopy
Quantity
619 units total (90 units in US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

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

Distribution pattern

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.