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Recall Observatory FDA recall evidence

Device product

Capnostream20 (US)M REFURBISHED, Part Number CS78653

Z-0033-2019

July 31, 2018

Class II

Product summary

Firm
Oridion Medical 1987 Ltd.
Event
Event 80895
Status
Terminated
Classification
Class II
Quantity
43
Official record key
device-enforcement:Z-0033-2019

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: 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.

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.