FDA Device recall Z-0324-2025
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio)
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio) by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0324-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-11 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
Reason
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.
Identifiers
| code_info | Software Versions: Software Version V2.1.0, Release Date 12-Aug-2019 Connex Cardio Software Version V1.0.0 V1.1.1 1…Software Versions: Software Version V2.1.0, Release Date 12-Aug-2019 Connex Cardio Software Version V1.0.0 V1.1.1 18-Oct-2017 Units: 1) UDI/DI 00817655022598, Serial Numbers: 117460595592, 117460595593, 117500601372, 117500601373, 117500601374, 117500601375, 118040607879, 118040607880, 118070613199, 117500601376, 118070613204, 118070613205, 118070613206, 118070613207, 118290000487, 118340002360, 118350000586, 118350000874, 118420000133, 118420001242, 118420001243, 118420001244, 118420001245, 118420001246, 118420001247, 118420001248, 118440000341, 118440000343, 118440000344, 118440000345, 118440000346, 118440000347, 118440000348, 118440000349, 118440000350, 118440000351, 118440000352, 118440000353, 118440000354, 118440000355, 118440000416, 118440000417, 118440000418, 118440000419, 118440000420, 118440000421, 118440000422, 118440000423, 118440000424, 118440000425, 118440000426, 118440000427, 118440000428, 118440000429, 118440000430, 118440000431, 118440000432, 118440000433, 118440 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0324-2025%22
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