APTIO RACK OUTPUT MODULE
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling 441 Aptio Rack Output Modules due to the potential that units were shipped without a warning label for risk of interference to pacemaker functionality. The affected modules are identified by Siemens Material Numbers 10715432 and 10715434, with UDI 00630414594477. These products were distributed across 38 US states and multiple foreign countries including Canada, Australia, Germany, France, India, Indonesia, and others.
The source document does not specify a remedy or corrective action for consumers who may have received affected units.
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: 10715432, 10715434; UDI: 00630414594477
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.