Recall record at a glance
| Official record | Z-1629-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zeiss, Carl Inc. |
| Report date | Apr 15, 2020 |
| Recall initiation date | Oct 2, 2019 |
| Quantity | US: 600; Global: 1600 |
| Location | Thornwood, NY, United States |
Official product description
Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
Why the product was recalled
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
Distribution information
Worldwide Distribution - US Nationwide
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: FDA Mandated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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