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Recall Observatory FDA recall evidence

Device product

Atellica IM 1600 Analyzer, Material Number 11066000

Z-1300-2019

March 07, 2019

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 82602
Status
Terminated
Classification
Class II
Quantity
366
Official record key
device-enforcement:Z-1300-2019

Official wording

Reason: There were multiple issues identified in the system software which required an update.

Code information: UDI: 00630414002026

Distribution pattern: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There were multiple issues identified in the system software which required an update.