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Recall Observatory FDA recall evidence

Device product

CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV

Z-0055-2019

July 31, 2018

Class II

Product summary

Firm
Oridion Medical 1987 Ltd.
Event
Event 80895
Status
Terminated
Classification
Class II
Quantity
16
Official record key
device-enforcement:Z-0055-2019

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: ME30160001 ME30160002 ME30160003 ME30160004 ME30160005 ME30160006 ME30160007 ME30160008 ME30160009 ME30160010 ME30160011 ME30160012 ME30160013 ME30160014 ME30160015 ME30160016

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.