Oridion Medical 1987 Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0035-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659

Product Classification:

Class II

Date Initiated: July 31, 2018

Date Posted: October 10, 2018

Recall Number: Z-0035-2019

Event ID: 80895

Reason for Recall:

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.

Status: Terminated

Product Quantity: 22

Code Information:

B200001278 B300001166 B300001220 B300001070 B300001092 B300001097 B300001108 B300001172 B300001181 B300001185 B300001205 B300001278 B300001115 B500001885 B500001831 B300001015 B300001118 B500002336 B300001012 B300001132 B300001139 B500001819

Distribution Pattern:

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, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated