Carl Zeiss Meditec recalls
Carl Zeiss Meditec appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2022-03-16.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 10 |
|---|---|
| Published | 2012-11-28 to 2022-03-16 |
| By agency | FDA Device (10) |
| By classification | Class II (10) |
| By status | terminated (8), ongoing (2) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
FDA Device · Class II · 2022-03-16 · Carl Zeiss Meditec
Reason: Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. - Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
FDA Device · Class II · 2021-08-18 · Carl Zeiss Meditec
Reason: Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device. - The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high res…
FDA Device · Class II · 2020-01-08 · Carl Zeiss Meditec
Reason: 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. - VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser…
FDA Device · Class II · 2019-12-25 · Carl Zeiss Meditec
Reason: 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 im… - Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Z…
FDA Device · Class II · 2013-11-27 · Carl Zeiss Meditec
Reason: 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… - Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zei…
FDA Device · Class II · 2013-11-27 · Carl Zeiss Meditec
Reason: 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… - Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 3…
FDA Device · Class II · 2013-06-12 · Carl Zeiss Meditec
Reason: 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 (… - INTRABEAM Balloon Applicator Set
FDA Device · Class II · 2012-11-28 · Carl Zeiss Meditec
Reason: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. - INTRABEAM Balloon Applicator Set
FDA Device · Class II · 2012-11-28 · Carl Zeiss Meditec
Reason: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. - INTRABEAM Balloon Applicator Set
FDA Device · Class II · 2012-11-28 · Carl Zeiss Meditec
Reason: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.