FDA-Device2019-05-15Class II
Atellica IM 1600 Analyzer, Material Number 11066000
Siemens Healthcare Diagnostics, Inc.
Hazard
There were multiple issues identified in the system software which required an update.
Sold states
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.
Affected count
366
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica IM 1600 Analyzer, Material Number 11066000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1300-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief