Electrocardiograph DICOM Files Risk Patient Data Mismatch Due to Duplicate Identifiers
Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.
What this means for you
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: Class II recall with no reported illnesses or injuries. The hazard is potential data integrity failure in a cardiac monitoring device (duplicate UIDs causing patient-data mismatch), qualifying as a risk-of-harm product without reported injury, per Score 3 rubric criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling the Hillrom Welch Allyn Vision Express Holter Analysis System (an electrocardiograph for cardiac monitoring). The affected systems have software versions V6.1.0 through V6.4.1, released August 2, 2016. Approximately 1003 units have been distributed worldwide.
The systems have the potential to assign duplicate Unique Identifiers (UIDs) to cardiac exam files. If a system receiving the DICOM files, such as a Picture Archiving and Communication System (PACS), relies solely on the UID to accept exams, patient identification could be mismatched with their physiological data.
Healthcare facilities using affected equipment should contact Baxter Healthcare Corporation for additional information.
The recalled product
- Product
- Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- duplicate-identifier
- patient-data-mismatch
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)
- Software Versions: Software Version V6.1.0 - V6.4.1
- Release Date 02-Aug-2016 Units: 1) UDI/DI 00732094261301
- Serial Numbers: 116400529526
- 116410531595
- 116420531929
- 116420532394
- 116440534958
- 116440534959
- 116440534960
- 116500543068
- 116510544188
- 116510544192
- 116510544191
- 2) UDI/DI 00812345027051
- Serial Numbers: 116410531060
- 117210570806
- 115240259136
- 115350270162
- 115530286838
- 116130382969
Distribution
Distribution scope not specified by the agency.
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