Carl Zeiss Meditec, Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. Matched by name to CZMWY.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlexClass IIJan 14, 2022Optic nerve head angiography scan to be turned off due to it	Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.	Class IIDevices	Jan 14, 2022
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"Class IIJul 8, 2021Due to failure to acquire pre-market clearance for its high	Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging devic	Class IIDevices	Jul 8, 2021