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Carl Zeiss Meditec Recalls
10 recalls on record · November 28, 2012 to March 16, 2022 · Medical Devices
Recalls by year
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22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 16, 2022Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Hazard: Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
August 18, 2021Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Hazard: Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
January 8, 2020Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a no
Hazard: Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch.
December 25, 2019Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMa
Hazard: VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment. Suction loss can occur in phase 1 through phase 5. The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only. The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds.
November 27, 2013Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Me
Hazard: The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
November 27, 2013Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Medi
Hazard: The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
June 12, 2013Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000
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.
November 28, 2012Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended f
Hazard: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
November 28, 2012Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended f
Hazard: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
November 28, 2012Medical DevicesFDA
Carl Zeiss Meditec, Inc. recalls INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended f
Hazard: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.