Atellica IM H2n 10995591Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Her-2/neu (H2n) Atellica IM - RGT 50T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Aug 25, 2020Class IITerminated
Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.
Z-0115-2021 · Root cause: Process control · Recall details · FDA record ↗
Other SYSTEM, TEST, HER-2/NEU, MONITORING devices
- Atellica IM H2n Calibrator 10995592Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, HER-2/NEU, MONITORING1 recall0 reports
- ADVIA Centaur® H2n 10308994Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, HER-2/NEU, MONITORING1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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