# FDA recall Z-0705-2024

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

## Product

Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a)	QS6 AM12Q KIT AHA XML / QS6-BXXCS:  b)	QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX:  c)	QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX:  d)	QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA:  e)	QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX:  f)	QS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1:  g)	QS6 AM12Q TTL KIT  AHA / QS-6AC-XXAXX:  h)	QS6 AM12Q TTL KIT  AHA / QS-6AC-XXBXX:  i)	QS6 AM12Q TTL KIT  AHA XML / QS-6AC-XXAXA:  j)	QS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS:  k)	QS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA:  l)	QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA:  m)	QS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA:  n)	QS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA:  o)	QS6 AM12Q TTL KIT AHA XML / QS6-MXTCS:  p)	QS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB:  q)	QS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA:  r)	QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX:  s)	QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX:  t)	QS6 AM12Q TTL K

## 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-0705-2024
- **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-0705-2024

## Citation

> AI Analytics. FDA recall Z-0705-2024. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0705-2024. Source: US FDA. Licensed CC0.

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