Recall Z-2227-2021— Carl Zeiss Meditec, Inc.

Name: FDA recall Z-2227-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-08

Class II · Ongoing

Class II FDA medical device recall by Carl Zeiss Meditec, Inc., initiated 2021-07-08. It names one FDA 510(k) clearance: K181534. Product: Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000". Reason: Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device..

Recalling firm: Carl Zeiss Meditec, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-07-08
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

Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

Reason for recall

Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.

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