Contour Fabricators Inc recalls Zero-Gravity Radiation Protection System Radiology Personnel protective shield.

Recall date

September 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0080-2017

FDA classification

Class II

Brand / firm

Contour Fabricators Inc

Sold / distributed

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.)

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zero-Gravity Radiation Protection System Radiology Personnel protective shield.