Senographe Pristina EKB3Recalls & reported problems

Summary

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

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K162268, K172404); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Oct 24, 2025Open, Classified

   Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).

   Z-0875-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

2. Dec 26, 2023Open, Classified

   X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

   Z-0862-2024 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162268, K172404. One submission often covers many models, so check the product and lot details in each record.

• Z-2131-2019 · May 16, 2019 · Terminated
  GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe P