Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and mul...
FDA Device Recall #Z-2058-2018 — Class II — May 8, 2018
Recall Summary
| Recall Number | Z-2058-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 8, 2018 |
| Status | Terminated |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | Zeiss, Carl Inc |
| Location | Thornwood, NY |
| Product Type | Devices |
| Quantity | 1070 units to US |
Product Description
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.
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.
Distribution Pattern
USA (nationwide)
Lot / Code Information
Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes
Other Recalls from Zeiss, Carl Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1465-2022 | Class III | ZEISS Axio Observer 5 microscope, Product mater... | Jun 24, 2022 |
| Z-1629-2020 | Class II | Component for Laser Scanning Microscopes (LSM 7... | Oct 2, 2019 |
| Z-2441-2018 | Class II | Disinfection unit UV (432332-9020-000) for th... | May 29, 2018 |
| Z-0799-2014 | Class II | Compensator Slider Lambda 6x20 component (part ... | Dec 20, 2013 |
| Z-1744-2013 | Class II | Polarizer D Fixed w/Rotating Red 1 lambda plate... | May 28, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.