Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1600 Analyzer, Material Number 11066000

Recalled May 15, 2019 · FDA recall Z-1300-2019 · Siemens Healthcare Diagnostics

Hazard

There were multiple issues identified in the system software which required an update. · FDA Class II

Units

366

Sold at

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, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.

Description

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

Product

Atellica IM 1600 Analyzer, Material Number 11066000

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →