Landauer: Medical Device Recall in 2024 - (Recall #: Z-0616-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000

Product Classification:

Class II

Date Initiated: November 15, 2023

Date Posted: January 3, 2024

Recall Number: Z-0616-2024

Event ID: 93524

Reason for Recall:

MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction of the reader s LED beam profile with the nanoDot dosimeter. The second is debris formation due to drawer actuation, resulting in a change of reader response that may not be detectable unless known dose QCs are being run regularly.

Status: Completed

Product Quantity: 584 units

Code Information:

All serial numbers.

Distribution Pattern:

US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam

Voluntary or Mandated:

Voluntary: Firm initiated