Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1300-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Atellica IM 1600 Analyzer, Material Number 11066000

Product Classification:

Class II

Date Initiated: March 7, 2019

Date Posted: May 15, 2019

Recall Number: Z-1300-2019

Event ID: 82602

Reason for Recall:

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

Status: Terminated

Product Quantity: 366

Code Information:

UDI: 00630414002026

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated