PlainRecalls
FDA Devices Moderate Class II Terminated

STREAMLAB CORE UNIT / LYNX WITH IOM

Reported: October 31, 2018 Initiated: August 14, 2018 #Z-0215-2019

Product Description

STREAMLAB CORE UNIT / LYNX WITH IOM

Reason for Recall

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

Details

Units Affected
186 StreamLAB 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?
STREAMLAB CORE UNIT / LYNX WITH IOM. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 186 StreamLAB 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-0215-2019.