FDA Medical Device Recalls (openFDA)
Zeiss, Carl Inc: 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.
- Recall number
- Z-2058-2018
- Recalling firm
- Zeiss, Carl Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-05-08
- Posted
- 2018-06-09
- Terminated
- 2020-04-21
- Reason
- In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 1.Your firm will send an initial email to all known users advising them of the issue, the risk involved and associated mitigations until the units can be evaluated by Carl Zeiss service representatives, 2.Your firm will send a second written communication to each first line purchaser and to each known user site with the notice of action and warning to discontinue use of the component until it has been verified as defective or properly functioning, and 3.Your firm will dispatch factory trained service representatives to perform verification tests and to replace defective units as necessary, free of charge. CDRH approves the CAP subject to the following conditions: For further questions, please call (914) 747-1800.. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Corrective actions will be provided at no cost to the purchasers and completed by March 1, 2019.
- Quantity
- 1070 units to US
- Distribution
- USA (nationwide)
- Lot, serial or model codes
- Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REM
- 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