FDA (Devices) recall action 95559
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.
Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.
The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.
The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.
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.
Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.