FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA Inc.: Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
- Recall number
- Z-1423-2017
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Product
- Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
- Status
- Terminated
- Initiated
- 2017-02-20
- Posted
- 2017-02-28
- Terminated
- 2017-09-17
- Reason
- The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
- Root cause
- Labeling Change Control
- Action
- Siemens sent a Customer Advisory Notice letter on February 20, 2017 to affected customer. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens.
- Quantity
- 6 units
- Distribution
- Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
- Lot, serial or model codes
- 1010, 1015, 1034, 1044, 45503, 45537
- 510(k) numbers
- ["K141971"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1034973
- Firm city
- Knoxville
- Firm state
- TN
- 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