Baxter Healthcare recalls Hillrom Welch Allyn HScribe Holter System software versions V4.0.0, V4.34, V6.1.0, V6.4.1 due to potential duplicate patient identifiers causing misidentification in medical records.
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 their physiological data.
Baxter Healthcare is recalling specific versions of the Hillrom Welch Allyn HScribe Holter System software. The issue could cause duplicate patient identifiers, leading to incorrect medical records being linked to patients. This might result in misdiagnosis or treatment errors if the system's medical records are not properly matched.
The system may assign duplicate Unique Identifiers (UIDs) to patient records. If medical imaging systems (PACS) rely solely on these UIDs to match patient records, it could cause patient identification mismatches, potentially leading to incorrect medical treatments or misdiagnoses.
Healthcare providers using the Hillrom Welch Allyn HScribe Holter System with the specified software versions and serial numbers are affected. Patients using this system for ambulatory monitoring may be at risk of incorrect medical records if the system misidentifies patients.
Check for software versions V4.0.0, V4.34 (released October 26, 2005) or V6.1.0, V6.4.1 (released August 2, 2016). The affected units have specific UDI/DI numbers and serial numbers listed in the recall notice.
Verify your system's software version by checking the device settings or documentation. The affected versions are V4.0.0, V4.34, V6.1.0, and V6.4.1.
Compare your device's serial numbers with the list provided in the recall notice to determine if it is affected.
Software versions V4.0.0, V4.34 (released October 26, 2005), V6.1.0, and V6.4.1 (released August 2, 2016) are affected.
Check your device's software version and compare it with the affected versions listed. Also, verify your serial numbers against the provided list in the recall notice.
The system may assign duplicate patient identifiers, which could lead to incorrect medical records being linked to patients. This might cause misdiagnosis or treatment errors if the system's medical records are not properly matched.
We’ve drafted a message you can send Hillrom Welch Allyn to request your refund or repair — edit it as you like.
Subject: Recall Z-0320-2025 — Hillrom Welch Allyn Hillrom Welch Allyn Hello, I own a Hillrom Welch Allyn that is covered by recall Z-0320-2025 from Hillrom Welch Allyn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
