https://plainrecords.com/brand/carl-zeiss-meditec/New recalls of Carl Zeiss Meditec from FDA, CPSC and NHTSA records.en-ushttps://plainrecords.com/recall/device/z-2649-2026/https://plainrecords.com/recall/device/z-2649-2026/Wed, 08 Jul 2026 00:00:00 +0000Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.https://plainrecords.com/recall/device/z-1007-2022/https://plainrecords.com/recall/device/z-1007-2022/Wed, 04 May 2022 00:00:00 +0000High friction of the slider can cause the device to stick, or not move as intended.https://plainrecords.com/recall/device/z-0723-2022/https://plainrecords.com/recall/device/z-0723-2022/Wed, 16 Mar 2022 00:00:00 +0000Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.https://plainrecords.com/recall/device/z-2227-2021/https://plainrecords.com/recall/device/z-2227-2021/Wed, 18 Aug 2021 00:00:00 +0000Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.https://plainrecords.com/recall/device/z-1133-2021/https://plainrecords.com/recall/device/z-1133-2021/Wed, 24 Feb 2021 00:00:00 +0000When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screenhttps://plainrecords.com/recall/device/z-0613-2021/https://plainrecords.com/recall/device/z-0613-2021/Wed, 23 Dec 2020 00:00:00 +0000Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.https://plainrecords.com/recall/device/z-0770-2020/https://plainrecords.com/recall/device/z-0770-2020/Wed, 08 Jan 2020 00:00:00 +0000Under 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.https://plainrecords.com/recall/device/z-0680-2020/https://plainrecords.com/recall/device/z-0680-2020/Wed, 25 Dec 2019 00:00:00 +0000VisuMax 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.…https://plainrecords.com/recall/device/z-0108-2019/https://plainrecords.com/recall/device/z-0108-2019/Wed, 24 Oct 2018 00:00:00 +0000Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.https://plainrecords.com/recall/device/z-0001-2018/https://plainrecords.com/recall/device/z-0001-2018/Wed, 11 Oct 2017 00:00:00 +0000The device had an incorrect printed calibration value on the calibration certificate.https://plainrecords.com/recall/device/z-0357-2016/https://plainrecords.com/recall/device/z-0357-2016/Wed, 09 Dec 2015 00:00:00 +0000IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.https://plainrecords.com/recall/device/z-1049-2015/https://plainrecords.com/recall/device/z-1049-2015/Wed, 11 Feb 2015 00:00:00 +0000Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.https://plainrecords.com/recall/device/z-1153-2014/https://plainrecords.com/recall/device/z-1153-2014/Wed, 19 Mar 2014 00:00:00 +0000Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.https://plainrecords.com/recall/device/z-0333-2014/https://plainrecords.com/recall/device/z-0333-2014/Wed, 27 Nov 2013 00:00:00 +0000The 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.https://plainrecords.com/recall/device/z-1440-2013/https://plainrecords.com/recall/device/z-1440-2013/Wed, 12 Jun 2013 00:00:00 +0000Carl 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.https://plainrecords.com/recall/device/z-0404-2013/https://plainrecords.com/recall/device/z-0404-2013/Wed, 28 Nov 2012 00:00:00 +0000A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.https://plainrecords.com/recall/device/z-0105-2012/https://plainrecords.com/recall/device/z-0105-2012/Mon, 24 Oct 2011 00:00:00 +0000An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations.https://plainrecords.com/recall/device/z-3275-2011/https://plainrecords.com/recall/device/z-3275-2011/Fri, 23 Sep 2011 00:00:00 +0000Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems.https://plainrecords.com/recall/device/z-2989-2011/https://plainrecords.com/recall/device/z-2989-2011/Wed, 10 Aug 2011 00:00:00 +0000Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol,https://plainrecords.com/recall/device/z-2126-2011/https://plainrecords.com/recall/device/z-2126-2011/Mon, 02 May 2011 00:00:00 +0000A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patienthttps://plainrecords.com/recall/device/z-0904-2011/https://plainrecords.com/recall/device/z-0904-2011/Fri, 14 Jan 2011 00:00:00 +0000Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.https://plainrecords.com/recall/device/z-2048-2009/https://plainrecords.com/recall/device/z-2048-2009/Thu, 03 Sep 2009 00:00:00 +0000Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS.