FDA recall Z-0322-2025

Product

Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph

Reason for recall

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-10-11

Report date

2024-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0322-2025