# FDA recall Z-2035-2019

> **Spacelabs Healthcare, Inc.** · Class II · device recall initiated 2019-01-28.

## Product

Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

## Reason for recall

Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

## Distribution

Distribution was nationwide.  There was also government and military distribution.    Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherlands, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, and Viet Nam.

## Key facts

- **Recall number:** Z-2035-2019
- **Recalling firm:** Spacelabs Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-28
- **Report date:** 2019-07-31
- **Termination date:** 2022-02-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Snoqualmie, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2019

## Citation

> AI Analytics. FDA recall Z-2035-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2035-2019. Source: US FDA. Licensed CC0.

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