# FDA recall Z-1248-2022

> **Getinge Usa Sales Inc** · Class II · device recall initiated 2022-04-13.

## Product

Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc.  Model: CM320 WU

## Reason for recall

Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

## Distribution

US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.

## Key facts

- **Recall number:** Z-1248-2022
- **Recalling firm:** Getinge Usa Sales Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-13
- **Report date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2022

## Citation

> AI Analytics. FDA recall Z-1248-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1248-2022. Source: US FDA. Licensed CC0.

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