The Recall Desk
SevereFDA (Devices)·Z-1629-2020·Announced 2020-04-15

Zeiss Laser Scanning Microscope Component Recalled for Laser Safety Bypass

Zeiss is recalling a component for LSM 700, 800, and 900 microscopes because tilting the light arm can bypass laser safety, causing Class IIIB laser radiation emission.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect that bypasses safety controls, resulting in the emission of Class IIIB laser radiation, which poses a significant risk of injury.

Plain-English summary

Zeiss, Carl Inc is recalling a component used in Laser Scanning Microscopes (LSM 700, LSM 800, and LSM 900). The recall involves 600 units in the United States and 1,600 units globally, with distribution worldwide and nationwide in the US.

The recall is issued because tilting the transmitted light arm of the microscope to the end of its axis range can bypass laser safety controls. This specific issue occurs when a ZEISS inverted stage stand (Axio Observer or Axio Vert) is used as a component of the LSM 700, 800, or 900 system. The bypass results in the emission of Class IIIB laser radiation.

Users of these specific microscope configurations should stop using the affected components and contact Zeiss, Carl Inc for further instructions on remediation or replacement.

The recalled product

Product
Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
Manufacturer
Zeiss, Carl Inc

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • (LSM 700
  • LSM 800 and LSM 900)

Distribution

Distributed nationwide across the United States.