Oridion Medical 1987 Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0045-2019)

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 M ADULT ICU (CPM), CS08654RA

Product Classification:

Class II

Date Initiated: July 31, 2018

Date Posted: October 10, 2018

Recall Number: Z-0045-2019

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: 5

Code Information:

B3000011359 B300001366 B300001445 B300001452 B300001460

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