Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZE...
FDA Device Recall #Z-0799-2014 — Class II — December 20, 2013
Recall Summary
| Recall Number | Z-0799-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 20, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zeiss, Carl Inc |
| Location | Thornwood, NY |
| Product Type | Devices |
| Quantity | 335 units Total (14 domestically & 321 internationally) |
Product Description
Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.
Reason for Recall
Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.
Distribution Pattern
Worldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Hong Kong, India, Italy, Kosovo, Lithuania, Mexico, The Netherlands, New Zealand, Peru, Poland, Spain, and Taiwan.
Lot / Code Information
part number 473704-0000-000
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-2058-2018 | Class II | Cell Observer SD, DirectFRAP, Laser TIRF 1, Las... | May 8, 2018 |
| 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.