FDA recall Z-1234-2022

Karl Storz Endoscopy · Class II · device

Product

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.

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.

Key facts

Status: Ongoing
Initiation date: 2022-05-03
Report date: 2022-06-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: El Segundo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2022