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Zero-Gravity Radiation Protection System Radiology Personnel protective shield.

FDA Device Recall #Z-0080-2017 — Class II — September 9, 2016

Recall Summary

Recall Number Z-0080-2017
Classification Class II — Moderate risk
Date Initiated September 9, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Contour Fabricators Inc
Location Fenton, MI
Product Type Devices
Quantity 447

Product Description

Zero-Gravity Radiation Protection System Radiology Personnel protective shield.

Reason for Recall

Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury.

Distribution Pattern

Nationwide. Canada. AUSTRALIA AUSTRIA BELGIUM BRUNEI CHINA FRANCE GERMANY INDA INDONESIA ISRAEL ITALY KSA MALAYSIA NETHERLANDS POLAND QATAR QUEBEC SAUDI ARABIA SINGAPORE SOUTH AFRICA TAIWAN (R.O.C.)

Lot / Code Information

All serial numbers for all models listed below manufactured/distributed between June 28, 2010  August 25, 2016. Part No. : Description ZGM-6-.5H : Zero-Gravity floor unit ZGM-6-5ROUNDH : Zero-Gravity floor unit ZGM-6Demo : Zero-Gravity demo floor unit ZGCM-48 : Zero-Gravity ceiling mounted monorail with 48 boom arm ZGCM-48-SPECIAL : Zero-Gravity ceiling mounted monorail with 48 boom arm with monorail extension ZG48 : Zero-Gravity 48 boom arm assembly and body shield for monorail ZGCM-66 : Zero-Gravity ceiling mounted monorail with 66 boom arm ZGCM-HSA : Zero-Gravity ceiling mounted monorail with hinged swing arm ZGCH : Zero-Gravity ceiling mounted monorail Contour track with 48 boom arm ZGCH48 : Zero-Gravity 48 boom arm assembly and body shield for Contour track ZGHSA : Zero-Gravity single point, ceiling mount with hinged swing arm ZGCSP : Zero-Gravity single point, ceiling mount with hinged swing arm 29858 : Zero-Gravity floor unit

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.

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