# FDA recall Z-0706-2024

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

## Product

XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a)	XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX;  b)	XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX;  c)	XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX;  d)	XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ;  e)	XS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA;  f)	XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX;  g)	XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA;  h)	XS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC;  i)	XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA;  j)	XS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB;  k)	XS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB;  l)	XS6 WAM TTL SYS  AHA XML, XSCRIBE-6AA-BXAAA;  m)	XS6 WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB;  n)	XS6 WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX;  o)	XS6 WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA;  p)	XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB;  q)	XS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC;  r)	XS6 

## 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-0706-2024
- **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-0706-2024

## Citation

> AI Analytics. FDA recall Z-0706-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0706-2024. Source: US FDA. Licensed CC0.

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