EOS System X- ray beam Digital radiography system used in general radiographic examinations.

FDA Device Recall #Z-0529-2014 — Class II — November 7, 2013

Recall Summary

Recall Number Z-0529-2014
Classification Class II — Moderate risk
Date Initiated November 7, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm EOS Imaging
Location Paris France
Product Type Devices
Quantity 22 EOS systems are installed in US

Product Description

EOS System X- ray beam Digital radiography system used in general radiographic examinations.

Reason for Recall

EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

EOS System

Other Recalls from EOS Imaging

Recall # Classification Product Date
Z-1415-2021 Class II The EOSedge system may acquire two simultaneous... Dec 22, 2020
Z-3188-2018 Class II sterEOS workstation Aug 1, 2018
Z-2626-2017 Class II ROTH MOBELI Grab Handles used with EOS System: ... May 30, 2017
Z-0580-2014 Class II steroEOS Workstation with software versions: 1.... Nov 29, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.