Is APTIO INPUT/OUTPUT MODULE recalled?

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. Status: Voluntary: Firm initiated Initial Firm Notification: Letter Distribution: 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.

Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

Agency Publication Date: October 23, 2018

Affected Products

Product: APTIO INPUT/OUTPUT MODULE

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

Product: APTIO RACK INPUT MODULE

Siemens Material Numbers: 10703037, 10711144; UDI: 00630414594477

Product: APTIO CENTRIFUGE MODULE

Siemens Material Numbers: 10703032, 10713761; UDI: 00630414594477

Product: APTIO 15000 REFRIGERATED STORAGE MODULE

Siemens Material Numbers: 10703036, 10713762; UDI: 00630414594477

Product: APTIO 9000 REFRIGERATED STORAGE MODULE

Siemens Material Numbers: 10703049, 10715227; UDI: 00630414594477

Product: APTIO RACK OUTPUT MODULE

Siemens Material Numbers: 10715432, 10715434; UDI: 00630414594477

Product: STREAMLAB CORE UNIT / LYNX WITH IOM

Siemens Material Numbers: 10444806; UDI: 00630414949765

Product: STREAMLAB - REFRIGERATED STORAGE MODULE 9000

Siemens Material Numbers: 10482426, 10464532, 10635930; UDI: 00630414949765

Product: STREAMLAB - REFRIGERATED STORAGE MODULE 15000

Siemens Material Numbers: 10482428; UDI: 00630414949765

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81047

Status: Resolved

Manufacturer: Siemens Healthcare Diagnostics, Inc.

Manufactured In: United States

Units Affected: 9 products (441 Aptio Automation Modules; 441 Aptio Automation Modules; 441 Aptio Automation Modules; 441 Aptio Automation Modules; 441 Aptio Automation Modules; 441 Aptio Automation Modules; 186 StreamLAB Automation Modules; 186 StreamLAB Automation Modules; 186 StreamLAB Automation Modules)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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