# FDA recall Z-0844-2018

> **Toshiba American Medical Systems Inc** · Class II · device recall initiated 2017-12-29.

## Product

INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

## Reason for recall

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

## Distribution

United States

## Key facts

- **Recall number:** Z-0844-2018
- **Recalling firm:** Toshiba American Medical Systems Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-29
- **Report date:** 2018-03-14
- **Termination date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0844-2018

## Citation

> AI Analytics. FDA recall Z-0844-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0844-2018. Source: US FDA. Licensed CC0.

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