Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
This recall has been completed (originally issued December 22, 2023).
- Recall Initiated
- November 15, 2023
- Posted
- December 22, 2023
- Recall Number
- Z-0616-2024
- Quantity
- 584 units
- Firm Location
- Glenwood, IL
- Official Source
- View on FDA website ↗
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
Lot / Code Info
All serial numbers.
Root Cause
Other
Action Taken
Landauer 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.