# FDA recall Z-0808-2022

> **GE Healthcare, LLC** · Class II · device recall initiated 2022-01-28.

## Product

GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

## Reason for recall

If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

## Distribution

Worldwide distribution - US nationwide, including Puerto Rico.  There was also government/military distribution. The countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cote d'lvoire, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Ghana, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Myanmar, Netherlands, Nigeria, Norway, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.

## Key facts

- **Recall number:** Z-0808-2022
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-28
- **Report date:** 2022-03-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0808-2022

## Citation

> AI Analytics. FDA recall Z-0808-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0808-2022. Source: US FDA. Licensed CC0.

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