Proteus XRaRecalls & 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.

11 other recalls cover devices cleared under the same FDA submission (K993090); 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. Oct 24, 2024Open, Classified

   Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.

   Z-0550-2025 · Root cause: Equipment maintenance · FDA record ↗

2. Jul 12, 2024Open, Classified

   The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.

   Z-2733-2024 · Root cause: Error in labeling · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993090. One submission often covers many models, so check the product and lot details in each record.

• Z-2449-2019 · Aug 9, 2019 · Open, Classified
  Proteus XR/a (SlOK : K993090)
• Z-1752-2019 · Mar 29, 2019 · Terminated
  Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image qu
• Z-1248-2015 · Jan 30, 2015 · Terminated
  GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures.
• Z-0954-2015 · Dec 8, 2014 · Terminated
  GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
• Z-1988-2014 · Jun 4, 2014 · Terminated
  GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This d
• Z-0526-2010 · Aug 13, 2009 · Terminated
  GE Healthcare Proteus XR/a. Model # 2259988. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. The Silhouette FC is indicated for use in generating radiographic images of h
• Z-0842-2008 · Nov 1, 2007 · Terminated
  GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.
• Z-1713-2008 · Mar 29, 2007 · Terminated
  GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
• Z-1790-2012 · May 31, 2006 · Terminated
  GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human ana
• Z-1087-2007 · May 31, 2006 · Terminated
  GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.
• Z-0219-05 · Dec 30, 2004 · Terminated
  Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency