Oridion Medical 1987 Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0032-2019)

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) N REFURBISHED, Part Number CS78651

Product Classification:

Class II

Date Initiated: July 31, 2018

Date Posted: October 10, 2018

Recall Number: Z-0032-2019

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: 46

Code Information:

B200001005 B200001300 B200001477 B200001546 B200001548 B200001557 B200001560 B200001582 B200001583 B200001591 B200001598 B200001601 B200001603 B200001606 B200001631 B200001641 B200001817 B200001884 B200001920 B200001938 B200001977 B200001986 B200002051 B200002060 B200002070 B200002078 B200002134 B200002148 B200002163 B200001387 B200001569 B200001673 B200001679 B200001844 B200002025 B200002031 B200002145 B200001827 B200001137 B200001160 B200001310 B200001660 B200001872 B200002187 B400002132 B200001671

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