# FDA recall Z-1597-2018

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2018-01-26.

## Product

Biograph Horizon - PET/CT, PETsyngo VJ20A Software  Nuclear medicine/ xray diagnostic scanner.

## Reason for recall

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.

## Distribution

Worldwide distribution.  US nationwide,  Australia, France, India, Japan, and  Netherlands.

## Key facts

- **Recall number:** Z-1597-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-26
- **Report date:** 2018-05-09
- **Termination date:** 2018-10-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hoffman Estates, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1597-2018

## Citation

> AI Analytics. FDA recall Z-1597-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1597-2018. Source: US FDA. Licensed CC0.

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