Baxter Healthcare Corporation: Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer

Hazard

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 from the source

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. Quantity: 1369 units Lot/code info: 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, 118440000434, 118440000435, 118440000436, 118440000437, 118440000438, 118440000439, 118440000440, 118440000441, 118440000442, 118440000443, 118440000444, 118440000445, 118440000446, 118440000447, 118450000095, 91CC-RXX-WADX, 119010000553, 119080000336, 119110000838, 119110000917, 119190001425, 119210001310, 119230003328, 119300000806, 119360000493, 119370000813, 119370001060, 119370001061, 119370001062, 119370001063, 119370001064, 119370001065, 119370001066, 119390000161, 119390000162, 119390000163, 11939000

UPC codes

00817655022598, 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.