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U.S. Department of Health and Human Services

Class 2 Device Recall Landauer microSTARii

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 Class 2 Device Recall Landauer microSTARiisee related information
Date Initiated by FirmNovember 15, 2023
Date PostedDecember 22, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0616-2024
Recall Event ID 93524
510(K)NumberK192196 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductLandauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Landauer
2 Science Rd
Glenwood IL 60425-1531
For Additional Information ContactMr. Bernard Morris
425-446-5724
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionLandauer Issued an URGENT - Medical Device Recall notice to its consignees on 11/15/2023 via email. The notice explained the issue, potential risk, and requested return of the device.
Quantity in Commerce584 units
DistributionUS and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYE
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