Recall Z-1234-2022— Karl Storz Endoscopy
Class II · Ongoing
Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2022-05-03. It names one FDA 510(k) clearance: K202957. 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: The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue..
- Recalling firm
- Karl Storz Endoscopy
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-05-03
- Firm location
- El Segundo, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.