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

Siemens Healthcare Diagnostics, Inc.: APTIO 9000 REFRIGERATED STORAGE MODULE

Is my product affected?

APTIO 9000 REFRIGERATED STORAGE MODULE

  • UPC 00630414594477

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

What happened

Siemens Healthcare Diagnostics is recalling 441 Aptio 9000 Refrigerated Storage Modules because they may have been shipped without a warning label regarding potential risk of interference to pacemaker functionality. The affected modules were distributed across 38 US states and multiple foreign countries including Australia, Austria, Canada, France, Germany, Italy, and others. The recalled products are identified by Siemens Material Numbers 10703049 and 10715227, and UDI 00630414594477.

The source document does not specify a remedy or corrective action for consumers who have this product.

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: 10703049, 10715227; 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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