Recall Z-0723-2022— Carl Zeiss Meditec, Inc.

Name: FDA recall Z-0723-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-14

Class II · Ongoing

Class II FDA medical device recall by Carl Zeiss Meditec, Inc., initiated 2022-01-14. It names one FDA 510(k) clearance: K181534. 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..

Recalling firm: Carl Zeiss Meditec, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-01-14
Firm location: Dublin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K181534 — CIRRUS HD-OCTCarl Zeiss Meditec, Inc.·cleared 2019-02-15

K-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

CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.