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Carl Zeiss Meditec, Inc. Recall 89524

Description: CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Carl Zeiss Meditec, Inc. Recall 89524 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0723-2022
Event ID89524
Event DescriptionCIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Product TypeDevices
DistributionU.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY, WY, WA, MN, NE, PA, SD, AZ, PR, TN, GA, FL, DE, NY, NH, TX, MS, MA, NV, UT, WV, ME, CO, AK, NM, KS, MO, MI, MD, ID, CT, NJ, MT, NC, VA, HI, VT, ND, SC, DC, RI
Quantity1,272 devices
Recall ReasonOptic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Device Classification20220316
Device Code InfoAll instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
Center Classification Date20220304
Recall Initiation Date20220114
Recalling FirmCarl Zeiss Meditec, Inc.
Initial Notification Letter
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