Home / Recalls / Landauer / Z-1349-2024

Z-1349-2024 Class II

Recalled by Landauer — Glenwood, IL

Recall Details

Product Type
Devices
Report Date
March 27, 2024
Initiation Date
February 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
975 units

Product Description

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

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.

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.

Code Information

All Lot/Serial Numbers:

Other recalls by Landauer

  • Z-0616-2024 Class II — Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000 (November 15, 2023)
  • Z-2565-2023 Class II — Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; (July 12, 2023)
  • Z-2561-2023 Class II — nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monito (July 12, 2023)
  • Z-2568-2023 Class II — QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) (July 12, 2023)
  • Z-2552-2023 Class II — QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring (July 12, 2023)
  • Z-2559-2023 Class II — Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VI (July 12, 2023)
  • Z-2545-2023 Class II — nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; (July 12, 2023)
  • Z-2569-2023 Class II — QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) (July 12, 2023)
  • Z-2558-2023 Class II — QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN00 (July 12, 2023)
  • Z-2551-2023 Class II — QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring (July 12, 2023)