Iba Dosimetry recalls Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

Recall date

April 26, 2017

Source

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

Recall number

Z-2220-2017

FDA classification

Class II

Brand / firm

Iba Dosimetry

Sold / distributed

Worldwide Distribution - USA (nationwide) and to the countries of : Argentina, Australia, Austria, Canada, Cyprus, France, Germany, Hong Kong, Ireland, Islamic Republic of, Israel, Italy, Japan, Kingdom of Saudi Arabia, Kuwait, New Zealand, People's Republic of China, Philippines, Russia, Slovakia,…

Why it was recalled

When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of measured profiles may appear.

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

What was recalled

Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T