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Recall Observatory FDA recall evidence

Device 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

Z-1349-2024

February 08, 2024

Class II

Product summary

Firm
Landauer
Event
Event 94043
Status
Completed
Classification
Class II
Quantity
975 units
Official record key
device-enforcement:Z-1349-2024

Official wording

Reason: 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.

Code information: All Lot/Serial Numbers:

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.