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fda_recall · device_recall · high

Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

Event date
2024-11-13 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-0323-2025
Payload hash
6ee3fb3f5eae6cba632c5f3a

Summary

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with th… Status: Ongoing.

Frequently asked questions

Has Baxter Healthcare Corporation had other FDA enforcement actions?
Yes. Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 208 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-11-13; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2024). Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-0323-2025
MLA
"Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-0323-2025.
Chicago
Argus HQ Research. "Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-0323-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_0323_2025_2024,
  title = {Baxter Healthcare Corporation — Class II recall: Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-0323-2025},
  note = {Accessed: July 17, 2026}
}

Informational only. Not legal, financial, or medical advice.