Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Summary
The FDA issued a Class II for Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000 by Landauer. Reason: MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction .
Details
Source
Device Recall
External ID
Z-0616-2024
Action Date
2024-01-03
Status
Completed
Category
device
Product Description
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Lot/Code Info: All serial numbers.
Quantity Affected: 584 units
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
US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-15
Company
Glenwood, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 94 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Landauer has 40 FDA actions in our database, including 40 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Landauer) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Landauer have FDA actions?
Landauer has 40 FDA actions in our database, including 40 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0616-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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