FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer, Material Number 11066000
- Recall number
- Z-1300-2019
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica IM 1600 Analyzer, Material Number 11066000
- Status
- Terminated
- Initiated
- 2019-03-07
- Posted
- not on file
- Terminated
- 2020-08-20
- Reason
- There were multiple issues identified in the system software which required an update.
- Root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers.
- Quantity
- 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.
- Lot, serial or model codes
- UDI: 00630414002026
- 510(k) numbers
- ["K151792"]
- PMA numbers
- not on file
- Product code
- JLW
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28