PlainRecalls
FDA Devices Moderate Class II Terminated

APTIO INPUT/OUTPUT MODULE

Reported: October 31, 2018 Initiated: August 14, 2018 #Z-0209-2019

Product Description

APTIO INPUT/OUTPUT MODULE

Reason for Recall

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

Details

Units Affected
441 Aptio Automation Modules
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.
Location
Tarrytown, NY

Frequently Asked Questions

What product was recalled?
APTIO INPUT/OUTPUT MODULE. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 441 Aptio Automation Modules.
Why was this product recalled?
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 31, 2018. Severity: Moderate. Recall number: Z-0209-2019.