Dublin, CA, United States
Carl Zeiss Meditec, Inc. recalls
4 recalls recorded since 2018, most recently on 14 January 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 14 January 2022
- Reason
- Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
- Distribution
- U.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY, WY, WA, MN, NE, PA, SD, AZ, PR, TN, GA, FL, DE, NY, NH, TX, MS, MA, NV, UT, WV, ME, CO, AK, NM, KS, MO, MI, MD, ID, CT, NJ, MT, NC, VA, HI, VT, ND, SC, DC, RI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0723-2022
- CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Ongoing Class II Medical devices
- Recall started
- 8 July 2021
- Reason
- Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2227-2021
- Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Terminated Class II Medical devices
- Recall started
- 6 December 2018
- Terminated
- 2 February 2021
- 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 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.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0680-2020
- VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product
Terminated Class II Medical devices
- Recall started
- 16 October 2018
- Terminated
- 11 June 2021
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, TX, NY, MA, OH, PA, IA, , KY, FL, MI, IL, MD and Germany, Japan, Switzerland, France Italy, Australia, Austria, Korea, China, India, Canada, Singapore, Norway, Taiwan, Israel, UAE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0770-2020
- 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 resolution, wide field of view tomographic and biomicroscopic imaging device intend
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.