Oridion Medical 1987 Ltd. recalls CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

Recall date

July 31, 2018

Source

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

Recall number

Z-0027-2019

FDA classification

Class II

Brand / firm

Oridion Medical 1987 Ltd.

Sold / distributed

The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel,…

Why it was recalled

The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

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

What was recalled

CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03