Home / Recalls / Medical Devices
Carl Zeiss Meditec, Inc. recalls Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000
Recalled June 12, 2013 · FDA recall Z-1440-2013 · Carl Zeiss Meditec
Hazard
Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount. · FDA Class II
Units
6 units
Sold at
US Nationwide Distribution.
Description
Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.
Product
Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
Manufacturer(s)
Carl Zeiss Meditec, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →