Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
FDA device recall Z-0616-2024 · posted 2023-12-22 · Completed
Recall details
- Recalling firm
- Landauer
- 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.
- 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.
- Root cause
- Other
- Status
- Completed
- Product code
- IYE
- Quantity affected
- 584 units
- Distribution
- US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam
- Date initiated
- 2023-11-15
- Date posted
- 2023-12-22
- Location
- Glenwood, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medical Radiation Dosimetry System microSTARii (K192196) | Landauer | 2019-12-27 |