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

Recall date

August 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0213-2019

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

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,…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

APTIO 9000 REFRIGERATED STORAGE MODULE