Z-1349-2024Class II

microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed...

Name: Z-1349-2024 microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed...
Creator: Landauer
Published: 2024-02-08
License: https://open.fda.gov/license/

Landauer / initiated 2024-02-08 / Completed / root cause: software

FDA source

Landauer began a recall of microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000... on 2024-02-08. FDA classified it as Class II and gives the reason as "Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-1349-2024
Classification: Class II
Status: Completed
Initiated: 2024-02-08
Posted: 2024-03-21
Recalling firm: Landauer
Product: microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
Product code: LHO Instrument, Quality-Assurance, Radiologic
Reason for recall: Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications.
Root cause tag: software
FDA root cause: No Marketing Application
Action: LANDAUER issued an URGENT - Medical Device Recall - RESPONSE REQUIRED notice to its consignees via email on 02/08/2024. The notice explained the firm was divesting itself of its therapy physics businesses and initiated this action to remove all reference to use of the microStar readers with the nanoDot or any other dosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications. The actions to be taken by customer/user are as follows: If using the product for medical applications only: 1. Immediately discontinue use of microStar reader 2. Fill out Business Reply Form 3. Return affected product to Sedgwick, a third-party recall firm that is assisting Landauer with this action), in accordance with the instructions below. If using the product for non-medical applications only: 1. Fill out Business Reply Form 2. Update Software by logging into https://ftp.landauer.com/, using following credentials and follow the instructions to install the new software. Username: microstar6 Password: Hsdtduw3w7284*@ 3. Review the revised User Manual available at https://www.landauer.com/user-manuals. Please refer to the User Manual provided by this link before using the product; all older versions are obsolete. If using the product for medical and non-medical applications: 1. Immediately discontinue use of microStar reader for medical applications 2. Fill out Business Reply Form 3. Update Software by logging into https://ftp.landauer.com/, using following credentials and follow the instructions to install the new software. Username: microstar6 Password: Hsdtduw3w7284*@ 4. Review the revised User Manual available at https://www.landauer.com/user-manuals. Please refer to the User Manual provided by this link before using the product; all older versions are obsolete. If using the product for medical applications only, uninstall the microStar software from the laptop and discard
Quantity in commerce: 975 units
Distribution: Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Brazil, Canada, China, France, India, Japan, Jordan, Malaysia, Mexico, Pakistan, Peru, Philippines, Rep of Korea, Singapore, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, Viet Nam.
Product codes and lots: All Lot/Serial Numbers:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1349-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1349-2024	Class II	Completed	Voluntary: Firm initiated	2024-03-27	2024-03-21

Product code LHO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)