Device recall: Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
Class II FDA enforcement event 84163. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Zeiss, Carl Inc started this device recall on 2 Oct 2019. The firm address in the FDA record is in Thornwood, NY. FDA put the recall in Class II. FDA event 84163 has 1 product record. The first FDA enforcement report date is 15 Apr 2020. The record gives the status Terminated, with the termination date 25 Jul 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US Nationwide
Recalling firm
Zeiss, Carl Inc, Thornwood, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1629-2020 | Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900) | US: 600; Global: 1600 | Class II | Terminated | 15 Apr 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Jun 2022 | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 | Device | Class III | 1 |
| 29 May 2018 | Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope | Device | Class II | 1 |
| 8 May 2018 | Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Mi | Device | Class II | 1 |
| 20 Dec 2013 | Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio I | Device | Class II | 1 |
| 28 May 2013 | Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of c | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1629-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 84163. https://recallregister.com/fda/ii/84163/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US Nationwide
- What quantity of product is in FDA event 84163?
- The FDA record gives this quantity:
US: 600; Global: 1600
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.