Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
Reported: November 13, 2024 Initiated: October 11, 2024 #Z-0324-2025
Product Description
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 1369 units
- Distribution
- Worldwide distribution.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer. Recalled by Baxter Healthcare Corporation. Units affected: 1369 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0324-2025.
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