The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0707-2024·Announced 2024-01-17

Cardiac Stress Testing Device May Produce Distorted ECG Readings

The XScribe CP Cardiac Stress Testing System (version 6) is being recalled because it may produce distorted electrocardiogram readings when the Source Consistency Filter is enabled, which could affect the accuracy of cardiac test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a high-risk medical device used for cardiac diagnosis. Although no illnesses or injuries have been reported, the identified defect in ECG readings poses a risk of patient harm through misdiagnosis or missed cardiac conditions. This meets the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Baxter Healthcare Corporation is recalling the XScribe CP Cardiac Stress Testing System, version 6. The recall affects approximately 1,675 units that have been distributed globally, including to the United States, Puerto Rico, Canada, Australia, and numerous countries in Asia, Africa, Europe, and Latin America.

The device has been recalled due to a potential defect: it may produce distorted electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. Distorted ECG readings could result in misinterpretation of cardiac test results and may impact clinical decision-making.

Healthcare facilities and patients who have undergone cardiac stress testing with affected XScribe CP systems should contact their healthcare providers to determine whether their test results may have been affected. Facilities using these devices should check the product code and serial numbers against the FDA recall notice and follow remediation guidance from Baxter Healthcare Corporation.

The recalled product

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…
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device
Hazard
Affected units
1,675

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Product Code
  • UDI/DI Number
  • Serial Numbers a) 41000-030-50
  • UDI/DI None
  • Serial Numbers: 110120039437
  • 110120039438
  • 110120039439
  • 110190044556
  • 110190044557
  • 110190044558
  • 110190044559
  • 110190044560
  • 110190044561
  • 110190044562
  • 110190044563
  • 110190044564
  • 110190044565
  • 110190044566
  • 110190044567
  • 110200045831

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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