Atellica IM 1600 Analyzer, Material Number 11066000
Reported: May 15, 2019 Initiated: March 7, 2019 #Z-1300-2019
Product Description
Atellica IM 1600 Analyzer, Material Number 11066000
Reason for Recall
There were multiple issues identified in the system software which required an update.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 366
- Distribution
- 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.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica IM 1600 Analyzer, Material Number 11066000. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 366.
Why was this product recalled? ▼
There were multiple issues identified in the system software which required an update.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2019. Severity: Moderate. Recall number: Z-1300-2019.
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