Recall Z-0616-2024 ยท IYE Accelerator, Linear, Medical
Landauer
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000
| Date | Dec 22, 2023 (initiated Nov 15, 2023) |
| Status | Completed |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 584 units |
| Distribution | US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192196 | Medical Radiation Dosimetry System microSTARii Landauer, Dec 27, 2019 |