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Recall Observatory FDA recall evidence

Device product

Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000

Z-1870-2021

May 04, 2021

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 87953
Status
Ongoing
Classification
Class II
Quantity
2,153 units
Official record key
device-enforcement:Z-1870-2021

Official wording

Reason: Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results

Code information: Software version: 1.24.0 SP1 or lower

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Croatia Cura¿ao, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Vatikancity, Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results