# FDA recall Z-1927-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2021-04-19.

## Product

Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application

## Reason for recall

If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.

## Distribution

Worldwide distribution - US Nationwide. Government/military distribution was also made, and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Czechia, Denmark, Estonia, Fiji, Finland,  France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Mexico, Moldova, Myanmar, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.

## Key facts

- **Recall number:** Z-1927-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-19
- **Report date:** 2021-06-30
- **Termination date:** 2026-01-14

- **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-1927-2021

## Citation

> AI Analytics. FDA recall Z-1927-2021. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1927-2021. Source: US FDA. Licensed CC0.

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