Z-0217-2019 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

Recall Details

Product Type
Devices
Report Date
October 31, 2018
Initiation Date
August 14, 2018
Termination Date
September 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
186 StreamLAB Automation Modules

Product Description

STREAMLAB - REFRIGERATED STORAGE MODULE 15000

Reason for Recall

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

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.

Code Information

Siemens Material Numbers: 10482428; UDI: 00630414949765