FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
- Recall number
- Z-1597-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
- Status
- Terminated
- Initiated
- 2018-01-26
- Posted
- not on file
- Terminated
- 2018-10-12
- Reason
- Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data reconstruction, incorrect values are being applied. This can lead to a gradient in the image. The severity of the error is directly related to the positioning of the PET QC phantom relative to the center of the field of view.
- Root cause
- Software Design Change
- Action
- Customers were notified via letter on approximately 01/26/2018. Instructions included to ensure proper positioning of the PET QC Phantom when performing the PET Quality Control Procedure by following section 6.3.1 in the Biograph Horizon Operator's Manual for Examination and Acquisition, complete the software update to PETsyngo VJ20B, ensure the recall notice is placed in the Biograph Horizon Operator's Manual for Examination and Acquisition and disseminated to all operators of the Biograph Horizon. If the equipment has been sold to another customer, they are instructed to provide the recall notice to the new owner.
- Quantity
- 42 units
- Distribution
- Worldwide distribution. US nationwide, Australia, France, India, Japan, and Netherlands.
- Lot, serial or model codes
- Software version VJ20A. Code No. 10532746, 10532748.
- 510(k) numbers
- ["K170904"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1000514697
- Firm city
- Hoffman Estates
- Firm state
- IL
- 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