# FDA recall Z-0176-2019

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2018-09-13.

## Product

Terumo¿ Advanced Perfusion System 1 Electronic Patient  Gas System, Catalog#: 801188

## Reason for recall

The service manual was not updated at the time of the release of software version 1.30.

## Distribution

US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, MI, MN, MO, OH, OR, PA, SC, TN, TX, WA, WI, and Puerto Rico.    The products were distributed to the following foreign countries:  Antioquia, Australia, Bangkok, Bangladesh, Belgium, Canada, Chile, China, Columbia, Dominican Republic, Ecuador, El Salvador, France, Germany, Guatemala, India, Indonesia, Japan, Korea, Kuwait, Malaysia, Metro Manilla, Mexico, New Delhi, New Zealand, Panama, Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Thailand, and Vietnam.

## Key facts

- **Recall number:** Z-0176-2019
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-13
- **Report date:** 2018-10-24
- **Termination date:** 2019-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2019

## Citation

> AI Analytics. FDA recall Z-0176-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0176-2019. Source: US FDA. Licensed CC0.

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