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Completed

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

FDA Recall Z-0616-2024 · Posted 2023-12-22

Recalling FirmLandauer
Recall StatusCompleted
Product CodeIYE
Date Initiated2023-11-15
Product Quantity584 units

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.

Firm Action

Landauer Issued an URGENT - Medical Device Recall notice to its consignees on 11/15/2023 via email. The notice explained the issue, potential risk, and requested return of the device.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192196Medical Radiation Dosimetry System microSTARiiLandauer · 2019-12-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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