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

FDA device recall Z-1349-2024 · posted 2024-03-21 · Completed

Recall details

Recalling firm

Landauer

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.

Action taken

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

Root cause

No Marketing Application

Status

Completed

Product code

LHO

Quantity affected

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

Date initiated

2024-02-08

Date posted

2024-03-21

Location

Glenwood, IL