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MOSAIQ (UDI 00858164002251)Recalls & reported problems

Elekta Solutions AB · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K183034); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Sep 24, 2019Open, Classified

    The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.

    Z-1597-2020 · Root cause: Software design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183034. One submission often covers many models, so check the product and lot details in each record.

  • Z-2591-2021 · Sep 2, 2021 · Open, Classified
    MOSAIQ Oncology Information System
  • Z-1783-2021 · Apr 20, 2021 · Terminated
    Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud

Other Accelerator, Linear, Medical devices

All Accelerator, Linear, Medical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.