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Recall Observatory FDA recall evidence

Device product

Capnostream20 (INTL) M REFURBISHED, CS78654

Z-0052-2019

July 31, 2018

Class II

Product summary

Firm
Oridion Medical 1987 Ltd.
Event
Event 80895
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-0052-2019

Official wording

Reason: 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.

Code information: B300001467 B300001028 B300001013 B300001063 B300001239 B300001299 B300001432 B300001465 B300001233 B500001792 B500001690

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.