PlainRecalls
FDA Devices Moderate Class II Terminated

APTIO 15000 REFRIGERATED STORAGE MODULE

Reported: October 31, 2018 Initiated: August 14, 2018 #Z-0212-2019

Product Description

APTIO 15000 REFRIGERATED STORAGE 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 15000 REFRIGERATED STORAGE 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-0212-2019.