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Recall Observatory FDA recall evidence

Device product

Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.

Z-0863-2021

December 02, 2020

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 86970
Status
Terminated
Classification
Class II
Quantity
1588 units
Official record key
device-enforcement:Z-0863-2021

Official wording

Reason: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

Code information: Software (SW) versions V1.23.2 (SMN 11469032) or lower

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software v1.23.2 and lower-may