Z-2058-2018Class II

Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser...

Name: Z-2058-2018 Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser...
Creator: Zeiss, Carl Inc
Published: 2018-05-08
License: https://open.fda.gov/license/

Carl Zeiss Microscopy, LLC / initiated 2018-05-08 / Terminated

FDA source

Zeiss, Carl Inc began a recall of Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes... on 2018-05-08. FDA classified it as Class II and gives the reason as "In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2058-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-08
Posted: 2018-06-09
Terminated: 2020-04-21
Recalling firm: Carl Zeiss Microscopy, LLC
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.
Product code: REM Spectroscopy Instrument
Reason for recall: In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
FDA 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 in commerce: 1070 units to US
Distribution: USA (nationwide)
Product codes and lots: Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2058-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2058-2018	Class II	Terminated	FDA Mandated	2018-06-20	2018-07-11

Product code REM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)