# FDA recall Z-1293-2021

> **Mizuho OSI** · Class II · device recall initiated 2021-02-08.

## Product

Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

## Reason for recall

There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.

## Distribution

Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.

## Key facts

- **Recall number:** Z-1293-2021
- **Recalling firm:** Mizuho OSI
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-08
- **Report date:** 2021-03-31

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1293-2021

## Citation

> AI Analytics. FDA recall Z-1293-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1293-2021. Source: US FDA. Licensed CC0.

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