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Recall Observatory FDA recall evidence

Device product

APTIO INPUT/OUTPUT MODULE

Z-0209-2019

August 14, 2018

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 81047
Status
Terminated
Classification
Class II
Quantity
441 Aptio Automation Modules
Official record key
device-enforcement:Z-0209-2019

Official wording

Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Code information: Siemens Material Numbers: 10703031, 10713760, 10713775, 10713772; UDI: 00630414594477

Distribution pattern: The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.