Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Reported: January 3, 2024 Initiated: November 15, 2023 #Z-0616-2024
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.
Details
- Recalling Firm
- Landauer
- Units Affected
- 584 units
- Distribution
- US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
- Location
- Glenwood, IL
Frequently Asked Questions
What product was recalled? ▼
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000. Recalled by Landauer. Units affected: 584 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 3, 2024. Severity: Moderate. Recall number: Z-0616-2024.
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