PlainRecalls
FDA Devices Moderate Class II Ongoing

STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT

Reported: June 15, 2022 Initiated: May 3, 2022 #Z-1234-2022

Product Description

STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT

Reason for Recall

The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.

Details

Recalling Firm
Karl Storz Endoscopy
Units Affected
401 units
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, and WY. The country of Canada.
Location
El Segundo, CA

Frequently Asked Questions

What product was recalled?
STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT. Recalled by Karl Storz Endoscopy. Units affected: 401 units.
Why was this product recalled?
The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 15, 2022. Severity: Moderate. Recall number: Z-1234-2022.