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Recall Observatory FDA recall evidence

Device product

E3800 PC Units (spare parts)

Z-1858-2021

April 14, 2021

Class II

Product summary

Firm
Radiometer Medical ApS
Event
Event 87870
Status
Ongoing
Classification
Class II
Quantity
Total 965 PC units World-wide (only 35 units in the U.S.)
Official record key
device-enforcement:Z-1858-2021

Official wording

Reason: Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Code information: Part number: 910-414

Distribution pattern: Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.