# FDA recall Z-1680-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-02-18.

## Product

PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

## Reason for recall

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

## Distribution

Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming

## Key facts

- **Recall number:** Z-1680-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-18
- **Report date:** 2020-04-15
- **Termination date:** 2021-02-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1680-2020

## Citation

> AI Analytics. FDA recall Z-1680-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1680-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*