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Recall Observatory FDA recall evidence

Device product

Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659

Z-0035-2019

July 31, 2018

Class II

Product summary

Firm
Oridion Medical 1987 Ltd.
Event
Event 80895
Status
Terminated
Classification
Class II
Quantity
22
Official record key
device-enforcement:Z-0035-2019

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: B200001278 B300001166 B300001220 B300001070 B300001092 B300001097 B300001108 B300001172 B300001181 B300001185 B300001205 B300001278 B300001115 B500001885 B500001831 B300001015 B300001118 B500002336 B300001012 B300001132 B300001139 B500001819

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.