Device product
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Z-1870-2021
Product summary
- 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
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results