APTIO INPUT/OUTPUT MODULE
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling 441 Aptio Input/Output Modules due to a labeling defect. The modules may have been shipped without a warning label indicating a potential risk of interference to pacemaker functionality. The affected products were distributed across 38 U.S. states and multiple foreign countries including Canada, Australia, and several European nations.
The recalled modules are identified by Siemens Material Numbers 10703031, 10713760, 10713775, and 10713772, with UDI 00630414594477. The source document 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: 441 Aptio Automation Modules Lot/code info: Siemens Material Numbers: 10703031, 10713760, 10713775, 10713772; UDI: 00630414594477
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.