FDA Medical Device Recalls (openFDA)
Zeiss, Carl Inc: Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
- Recall number
- Z-1629-2020
- Recalling firm
- Zeiss, Carl Inc
- Product
- Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
- Status
- Terminated
- Initiated
- 2019-10-02
- Posted
- not on file
- Terminated
- 2024-07-25
- 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
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The Company will immediately notify by fax or direct contact (when available) and/or express courier each consignee purchaser and/or known user site with the laser safety notice which advises of the issue, the risk involved and how to minimize the risk of occurrence.
- Quantity
- US: 600; Global: 1600
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- (LSM 700, LSM 800 and LSM 900)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RIB
- Firm FEI
- 2431026
- Firm city
- Thornwood
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28