Z-0616-2024Class II

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

Name: Z-0616-2024 Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Creator: Landauer
Published: 2023-11-15
License: https://open.fda.gov/license/

Landauer / initiated 2023-11-15 / Completed

FDA source

Landauer began a recall of Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 on 2023-11-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0616-2024
Classification: Class II
Status: Completed
Initiated: 2023-11-15
Posted: 2023-12-22
Recalling firm: Landauer
Product: Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Product code: IYE Accelerator, Linear, Medical
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.
FDA root cause: Other
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.
Quantity in commerce: 584 units
Distribution: US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0616-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0616-2024	Class II	Completed	Voluntary: Firm initiated	2024-01-03	2023-12-22

Product code IYE

K192196Class IIMedical Radiation Dosimetry System microSTARiiLandauer / cleared 2019-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)