Oridion Medical 1987 Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0033-2019)

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 REFURBISHED, Part Number CS78653

Product Classification:

Class II

Date Initiated: July 31, 2018

Date Posted: October 10, 2018

Recall Number: Z-0033-2019

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: 43

Code Information:

B300001025 B300001053 B300001106 B300001109 B300001140 B300001178 B300001219 B300001282 B300001304 B300001324 B300001262 B300001094 B300001177 B300001208 B300001242 B300001246 B300001313 B500002196 B300001188 B300001236 B300002173 B500002408 B300001071 B300001075 B300001124 B300001204 B300001248 B300001443 B500001655 B500001659 B500001660 B500001666 B500001670 B500001683 B500001701 B500001806 B500001817 B500002130 B500002189 B500002231 B300001066 B300001244 B300001207

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