Carl Zeiss Meditec, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0723-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Product Classification:

Class II

Date Initiated: January 14, 2022

Date Posted: March 16, 2022

Recall Number: Z-0723-2022

Event ID: 89524

Reason for Recall:

Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.

Status: Ongoing

Product Quantity: 1,272 devices

Code Information:

All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan

Distribution Pattern:

U.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

Voluntary or Mandated:

Voluntary: Firm initiated