Reported Jul 13, 2016 · Terminated

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

Karl Storz Endoscopy

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Karl Storz Endoscopy · 2151 E Grand Ave · El Segundo, CA · 90245-5017

Is this the product you have?

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

Lot codes and dates: 90 of 90 codes
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
Amount recalled: 619 units total (90 units in US)

Where it was sold

Why it was recalled

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).

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Karl Storz Endoscopy recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

By hazard

Medical device recalls

Other recalls from Karl Storz Endoscopy

Flexible Hystero-Fiberscope Kits Jul 29, 2026
KARL STORZ - ENDOSKOPE Feb 5, 2025
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE Jan 22, 2025
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full… Dec 4, 2024
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set… Nov 20, 2024
Karl Storz - Endoskope Oct 2, 2024

23 in total.

Where it was distributed

All recall categories · Browse the whole archive