# FDA recall Z-0322-2025

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2024-10-11.

## 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

- **Recall number:** Z-0322-2025
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-11
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0322-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0322-2025. Source: US FDA. Licensed CC0.

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