# FDA recall Z-0297-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2018-08-03.

## Product

Multix Fusion system is a radiographic system:  Models:  Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059);  Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042);  Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042);  Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)

## Reason for recall

Steel cables inside the lifting column of the overhead tube,  may rapture without triggering the safety lock, leading  to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning

## Distribution

US nationwide distribution

## Key facts

- **Recall number:** Z-0297-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-03
- **Report date:** 2018-11-07
- **Termination date:** 2019-11-26

- **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-0297-2019

## Citation

> AI Analytics. FDA recall Z-0297-2019. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0297-2019. Source: US FDA. Licensed CC0.

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