Discovery MI (UDI 00195278098603)Recalls & reported problems

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.

3 other recalls cover devices cleared under the same FDA submission (K161574, K211846); 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. Jun 2, 2022Open, Classified

   As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

   Z-1511-2022 · Root cause: Error in labeling · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161574, K211846. One submission often covers many models, so check the product and lot details in each record.

• Z-1749-2019 · Feb 12, 2019 · Open, Classified
  Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activi
• Z-2580-2018 · May 24, 2018 · Terminated
  Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
• Z-2193-2017 · May 19, 2017 · Terminated
  GE Healthcare Discovery Ml X-ray system