Oridion Medical 1987 Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0050-2019)

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 N CYVITAL, CS08799

Product Classification:

Class II

Date Initiated: July 31, 2018

Date Posted: October 10, 2018

Recall Number: Z-0050-2019

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: 20

Code Information:

B400002614 B400002628 B400002640 B400002642 B400002645 B400002646 B400002653 B400002658 B400002659 B400002660 B400002750 B400002760 B417135110 B417135186 B417135189 B418135223 B418135272 B418135278 B419135324 B419135329

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