Thornwood, NY, United States
Zeiss, Carl Inc recalls
4 recalls recorded since 2018, most recently on 24 June 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 24 June 2022
- Terminated
- 7 February 2025
- Reason
- An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
- Distribution
- US Nationwide distribution in the state of NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1465-2022
- ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Terminated Class II Medical devices
- Recall started
- 2 October 2019
- Terminated
- 25 July 2024
- Reason
- When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypassed and result in emission of class lIlb laser radiation. This issue arises when a ZEISS inverted stage stand (Axio Observer or Axio Vert) is used in as a component of the LSM 700, 800 and 900 system
- Distribution
- Worldwide Distribution - US Nationwide
- Initiated
- FDA Mandated
- Recall number
- Z-1629-2020
- Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
Terminated Class II Medical devices
- Recall started
- 29 May 2018
- Terminated
- 26 July 2024
- Reason
- Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users to harmful UV radiation.
- Distribution
- US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-2441-2018
- Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
Terminated Class II Medical devices
- Recall started
- 8 May 2018
- Terminated
- 21 April 2020
- Reason
- In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
- Distribution
- USA (nationwide)
- Initiated
- FDA Mandated
- Recall number
- Z-2058-2018
- Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.
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.