# FDA recall Z-0707-2024

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2023-12-08.

## Product

XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a)	X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50;  b)	X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51;  c)	X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52;  d)	X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53;  e)	XSCRIBE CP KIT WIRELESS, 41000-030-60;  f)	XSCRIBE CP KIT WIRED, 41000-030-62;  g)	XSCRIBE CP SW KIT, 41000-030-64

## Reason for recall

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

## Distribution

United States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Argentina, Bahamas, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, and Trinidad and Tobago.

## Key facts

- **Recall number:** Z-0707-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-08
- **Report date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0707-2024

## Citation

> AI Analytics. FDA recall Z-0707-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0707-2024. Source: US FDA. Licensed CC0.

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