STREAMLAB CORE UNIT / LYNX WITH IOM
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling 186 StreamLAB Core Unit/Lynx with IOM modules because they may have been shipped without a warning label regarding potential interference to pacemaker functionality. The affected modules have Siemens Material Number 10444806 and UDI 00630414949765, and were distributed across 38 U.S. states and multiple countries including Australia, Austria, Belgium, Canada, France, Germany, Italy, India, and others.
The recall notice does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Reason for recall: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. 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, L Quantity: 186 StreamLAB Automation Modules Lot/code info: Siemens Material Numbers: 10444806; UDI: 00630414949765
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.