Recall archive / FDA device enforcement

Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer — FDA record Z-0324-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 11, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Classification: Class II
Recalling firm: Baxter Healthcare Corporation
Quantity: 1369 units
Agency-reported status: Ongoing
Source record identifier: Z-0324-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, 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118070613209, 118070613210, 118080615506, 118080615507, 118080615508, 118080615509, 118080615510, 118080615511, 118080615512, 118100617237, 118100617238, 118100617239, 118100617240, 118100617241, 118100617242, 118100617243, 118100617244, 118100617245, 118100617246, 118100617247, 118100617249, 118100617250, 118100617251, 118100617252, 118100617253, 118100617254, 118100617255, 118100617256, 118100617257, 118100617258, 118100617259, 118100617260, 118100617261, 118100617262, 118100617263, 118100617264, 118100617265, 118100617266, 118100617267, 118100617268, 118100617269, 118100617270, 118100617271, 118100617272, 118100617273, 118100617274, 118100617248, 118250001251, 118250001252, 118250001255, 118250001256, 118250001257, 118250001258, 118250001259, 118250001260, 118250001261, 118250001262, 118250001263, 118250001264, 118250001265, 118250001266, 118250001267, 118250001268, 118250001269, 118250001270, 118250001271, 118250001272, 118250001273, 118250001274, 118250001275, 118250001276, 118250001277, 118250001278, 118250001279, 118250001280, 118250001281, 118250001282, 118250001283, 118250001284, 118250001285, 118250001286, 118250001287, 118250001288, 118250001289, 118250001290, 118250001291, 118250001292, 118250001293, 118250001294, 118250001295, 118250001296, 118250001297, 118250001298, 118250001299, 118250001300, 10081765502261100, 118290001236, 118290001237, 118390000375, 118390000376, 118390000377, 118390000378, 118390000379, 118460000961, 118250000897, 119100001128, 119100001129, 119100001130, 119100001131, 119100001132, 119100001133, 119100001134, 119100001135, 119100001136, 119100001137, 119100001138, 119100001139, 119100001140, 119170000209, 119170000210, 119210001410, 119210001411, 119210001412, 119210001413, 119210001414, 119210001415, 119210001416, 119210001418, 119210001419, 119210001420, 119210001422, 119210001423, 119210001424, 119210001485, 119210001486, 119210001487, 119210001488, 119210001489, 119210001490, 119210001491, 119210001492, 119210001493, 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120240001214, 120240001215, 120240001216, 120240001217, 120240001218, 120240001...

Label field

Details supplied by the agency

Lot, code or applicability

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, 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124080001392, 124080001393, 124090000193, 124090000194, 124090000195, 118440000351, 118440000443, 122480000569, 124030000222, 124040000748, 124040000749, 124040000750, 124040000751, 124040000752, 124110000713, 124170001449, 124170001450, 124170001451, 124190000655, 124190000656, 124190000657, 124190000658, 124190000659, 124190000660, 124190000661, 124190000662, 124190000663, 124190000664, 124190000665, 124190000666, 124190000667, 124190000668, 124190000669, 124200000063, 124200002640, 124200002641, 124220000129, 124220000130, 124230001175, 124230001176, 124230001177, 124230001178, 124230001179, 124230001180, 124260000634, 124260000635, 124260000636, 124260000637, 124260000638, 124260000639, 124260000640, 124260000641, 124260000642, 10081765502259800, 124070000340, 124080001389, 124080001390, 124080001391, 124080001392, 124080001393, 124090000193, 124090000194, 124090000195, 124110000713, 124110000714, 124110000715; 2) UDI/DI 00817655022611, Serial Numbers: 118070613209, 118070613210, 118080615506, 118080615507, 118080615508, 118080615509, 118080615510, 118080615511, 118080615512, 118100617237, 118100617238, 118100617239, 118100617240, 118100617241, 118100617242, 118100617243, 118100617244, 118100617245, 118100617246, 118100617247, 118100617249, 118100617250, 118100617251, 118100617252, 118100617253, 118100617254, 118100617255, 118100617256, 118100617257, 118100617258, 118100617259, 118100617260, 118100617261, 118100617262, 118100617263, 118100617264, 118100617265, 118100617266, 118100617267, 118100617268, 118100617269, 118100617270, 118100617271, 118100617272, 118100617273, 118100617274, 118100617248, 118250001251, 118250001252, 118250001255, 118250001256, 118250001257, 118250001258, 118250001259, 118250001260, 118250001261, 118250001262, 118250001263, 118250001264, 118250001265, 118250001266, 118250001267, 118250001268, 118250001269, 118250001270, 118250001271, 118250001272, 118250001273, 118250001274, 118250001275, 118250001276, 118250001277, 118250001278, 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120240001216, 120240001217, 120240001218, 120240001...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Nov 13, 2024
Recall initiation date: Oct 11, 2024
Center classification date: Nov 7, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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