FDAFDA · Food and drugs·Recall number Z-0212-2019
APTIO 15000 REFRIGERATED STORAGE MODULE
Published October 31, 2018 · Recall initiated: August 14, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- 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, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.
- Lot
- Siemens Material Numbers: 10703036, 10713762; UDI: 00630414594477
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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