Cirrus Hd-Oct…

Date

March 16, 2022

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Carl Zeiss Meditec, Inc.

Product

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Reason

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

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

Quantity

1,272 devices

Codes and lots

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

Recall started

Jan. 14, 2022

Device type

Tomography, Optical Coherence

Root cause (FDA)

No Marketing Application

What the company told customers

On 01/14/22, recall notices were mailed to customers who were asked to do the following: 1. Until further notice, please discontinue the acquisition of the ONH Angiography 4.5x4.5mm Scan. 2. Using the provided software kit(s), install software version 11.5.3 on all affected instruments. You will be receiving one software kit per affected instrument according to our records. An excerpt of the IFU has been included Section 4.7 Update Instrument Software, these instructions apply to all models. Refer to the IFU Section 4 for the full installation instructions. 3. Complete and return the Acknowledgement Form per the instructions in the attachment. In case you no longer have the device, we ask that you inform the recalling firm and forward this letter to the new owner. Customers with additional questions were encouraged to contact customer service at 1-800-341-6968 (select option 1, 1).

Recall number

Z-0723-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0723-2022. The agency record governs; check it and the company before acting.