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Medium RiskFDA Device
Medical Devices

Baxter Healthcare Corporation: Diagnostic Cardiology Systems Recalled for Patient Data Mismatch Risk

Agency Publication Date: November 7, 2024
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Summary

Baxter Healthcare is recalling approximately 6,597 units of various Hillrom Welch Allyn diagnostic cardiology systems, including HScribe, Q-Stress, and XScribe models. The recall was initiated because the software may assign duplicate identification numbers to different exam files. This defect can cause a patient's heart monitoring data or stress test results to be saved under a different patient's name in hospital database systems. Affected models were distributed worldwide and include software versions released between 2005 and 2019. Consumers should contact Baxter Healthcare or their healthcare provider for guidance on necessary software corrections.

Risk

If a hospital record system relies only on these identification numbers to accept files, the physiological data of one patient could be mistakenly attached to the record of another. This mismatch may lead to incorrect diagnoses or improper medical treatments based on the wrong patient's data.

What You Should Do

  1. Identify if your facility uses Hillrom Welch Allyn systems such as HScribe Holter, Q-Stress, RScribe ECG, Vision Express Holter, Diagnostic Cardiology Suite (formerly Connex Cardio), or XScribe systems.
  2. Check your device software version to see if it matches the affected ranges: HScribe (V4.0.0–V4.34 or V6.1.0–V6.4.1), Q-Stress (V6.0.0–V6.3.2), RScribe (V6.0.0–V6.2.3 or V7.0.0), Vision Express (V6.1.0–V6.4.1), Diagnostic Cardiology Suite (V2.1.0 or V1.0.0–V1.1.1), or XScribe (V6.0.0–V6.3.2).
  3. Verify the device serial number against the extensive lists provided for each UDI/DI, such as HScribe UDI 00732094263992 (SN 119470002280) or RScribe UDI 00732094262957 (SN 118100617841).
  4. Contact your healthcare provider or Baxter Healthcare Corporation directly at their Deerfield, Illinois headquarters for specific instructions on software patches or administrative steps to prevent data mismatch.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional technical questions or need to report incidents.

Your Remedy Options

📋Other Action

Risk assessment and software guidance for healthcare facilities

How to: Contact your healthcare provider or the manufacturer for further instructions and potential corrective software actions

Affected Products

Product: Hillrom Welch Allyn HScribe Holter System
Model / REF:
00732094263992
00732094264043
00732094264074
00732094264111
00732094296297
00817655020112
00817655020129
00817655020228
00817655020365
00817655020426
00817655021744
00817655022161
Lot Numbers:
V4.0.0 - V4.34
V6.1.0 - V6.4.1
Product: Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System
Model / REF:
00732094263213
00732094263237
00732094263336
00732094263374
00732094263381
00732094263398
00732094263411
00732094263428
00732094263435
00732094263626
00732094263671
00732094263879
00732094263893
00732094263930
00732094263947
00732094289169
00732094296273
00732094308426
00732094309645
00732094312898
00732094312904
00732094312928
00732094312942
00732094312966
00732094315660
00732094318029
00732094318432
00732094321029
00732094323726
00732094326604
00732094336054
00732094336061
00732094343786
00732094352672
00812345027563
00812345027570
00812345027587
00812345027594
00812345027624
00812345027723
00817655020754
Lot Numbers:
V6.0.0 - V6.3.2
Product: Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System
Model / REF:
00732094262957
00732094263046
00732094263107
00732094263138
00732094263152
00732094263169
00812345027822
00812345027839
00817655020280
00817655021362
00817655022246
Lot Numbers:
V6.0.0 - V6.2.3
V7.0.0
Product: Hillrom Welch Allyn Vision Express Holter Analysis System
Model / REF:
00732094261301
00812345027051
00812345027068
00812345027075
00812345027082
Lot Numbers:
V6.1.0 - V6.4.1
Product: Hillrom Welch Allyn Diagnostic Cardiology Suite
Model / REF:
00817655022598
00817655022611
Lot Numbers:
V2.1.0
V1.0.0 - V1.1.1 (Connex Cardio)
Product: Hillrom Welch Allyn XScribe Cardiac Stress Testing System
Model / REF (69):
00732094259032
00732094259070
00732094259100
00732094259148
00732094259179
00732094259230
00732094259261
00732094259285
00732094259292
00732094259308
00732094259315
00732094259322
00732094259346
00732094259445
00732094259506
00732094259575
00732094259612
00732094259650
00732094259681
00732094259735
00732094259766
00732094259810
00732094259889
00732094259919
00732094259971
00732094260120
00732094260137
00732094260151
00732094260199
00732094260229
00732094260267
00732094260304
00732094260342
00732094260380
00732094260434
00732094260519
00732094260533
00732094260557
00732094260601
00732094260670
00732094260731
00732094260816
00732094260847
00732094260885
00732094260892
00732094260960
00732094260991
00732094261004
00732094261028
00732094261042
Lot Numbers:
V6.0.0 - V6.3.2

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95559
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Hillrom; Welch Allyn; Baxter Healthcare Corporation; Medical device distributors; Hospitals
Manufactured In: United States
Units Affected: 6 products (599 units; 2461 units; 399 units; 1003 units; 1369 units; 766 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.