Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0214-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

APTIO RACK OUTPUT MODULE

Product Classification:

Class II

Date Initiated: August 14, 2018

Date Posted: October 31, 2018

Recall Number: Z-0214-2019

Event ID: 81047

Reason for Recall:

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

Status: Terminated

Product Quantity: 441 Aptio Automation Modules

Code Information:

Siemens Material Numbers: 10715432, 10715434; 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.

Voluntary or Mandated:

Voluntary: Firm initiated