Home / Recalls / Landauer / Z-0616-2024

Z-0616-2024 Class II

Recalled by Landauer — Glenwood, IL

Recall Details

Product Type
Devices
Report Date
January 3, 2024
Initiation Date
November 15, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
584 units

Product Description

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

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.

Distribution Pattern

US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam

Code Information

All serial numbers.

Other recalls by Landauer

  • Z-1349-2024 Class II — microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, (February 8, 2024)
  • 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)