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FDA (Device enforcement)Recalled 2018-08-14closedclass ii

Siemens Healthcare Diagnostics, Inc.: APTIO RACK INPUT MODULE

Is my product affected?

APTIO RACK INPUT MODULE

  • UPC 00630414594477

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics, Inc. is recalling 441 Aptio Rack Input Modules because they may have been shipped without a warning label for potential risk of interference to pacemaker functionality. The affected modules were distributed across 37 U.S. states, including Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and West Virginia, as well as to multiple foreign countries including Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, and Indonesia. The specific models involved have Siemens Material Numbers 10703037 and 10711144, with UDI 00630414594477.

The recall record does not specify a remedy or what actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 10703037, 10711144; UDI: 00630414594477

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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