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
Check against the official notice below — it lists the full affected range.
Karl Storz is recalling 401 units of STORZ KARL STORZ-ENDOSKOPE CMOS Video Cysto-Urethroscope models (reference numbers 11272VUE, 11272VUEK, and 11272VUE-R) due to a manufacturing assembly process issue that may cause the endoscope to lose image when monopolar electrocautery is activated. The recalled devices were distributed worldwide and across numerous U.S. states as well as Canada.
The affected devices can be identified by their scope base part number 11272VUE, scope kit part number 11272VUEK, or UDI code DI 4048551431382, along with specific serial numbers listed in the recall record. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
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. Quantity: 401 units Lot/code info: Scope Base Part Number(s): 11272VUE Scope Kit Part Number: 11272VUEK UDI Code-DI: 4048551431382 Serial Numbers: 25407 32321 38539 53439 58011 58143 58546 59051 25408 32389 40370 53574 58020 58144 58557 59063 25410 32391 40371 53575 58021 58145 58558 59093 25766 32417 40707 53589 58022 58156 58567 59094 28096 32994 40708 53593 58045 58157 58569 59095 28257 33787 41249 53627 58046 58183 58570 59096 28919 33802 44912 53628 58047 58184 58663 59098 29286 33804 45546 53632 58048 58185 58665 59122 29342 33905 46190 53634 58058 58423 58695 59125 30054 33907 46198 53637 58060 58445 58722 59152 30881 34465 47625 53737 58062 58446 58723 59153 31033 34724 47669 53776 58073 58449 58730 59179 31036 34725 48191 53833 58074 58451 58731 59201 31038 35188 48462 53834 58075 58476 59005 59202 31300 36020 48540 54289 58078 58498 59006 59203 31302 36371 48553 57603 58087 58503 59007 59223 31374 36470 49090 57606 58088 58506 59032 59342 31413 36583 49165 57607 58089 58508 59033 59343 31533 36820 52783 57609 58090 58516 59034 59344 31622 37462 53204 57610 58125 58517 59038 59345 31964 38536 53429 57986 58142 58545 59048 59398 59399 59630 59815 59939 60080 60352 60860 61226 59400 59631 59819 59940 60151 60385 60885 61228 59401 59632 59820 59968 60153 60386 60948 61230 59402 59633 59821 59969 60154 60416 60949 61236 59416 59635 59822 59970 60159 60417 61109 61238 59418 59637 59839 59971 60160 60418 61110 61242 59420 59639 59840 60001 60161 60430 61111 61243 59495 59640 59842 60002 60162 60520 61114 61
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.