Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1300 Analyzer, Material Number 11066001

Recall date

March 7, 2019

Source

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

Recall number

Z-1299-2019

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, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Austral…

Why it was recalled

There were multiple issues identified in the system software which required an update.

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

What was recalled

Atellica IM 1300 Analyzer, Material Number 11066001