Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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, 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123180000487, 123210000783, 123210000784, 123210000785, 123210000786, 123240000205, 123240000206, 123240000207, 123300002140, 123300002141, 123300002142, 123300002143, 123300002144, 123320000675, 123320000676, 123320000677, 123330000643, 123330000644, 123330000645, 123350000828, 123350000829, 123350000830, 123350000831, 123350000832, 123380000882, 123380000883, 123380000884, 123400000185, 123400000186, 123410000806, 123410000807, 123410000808, 123410000809, 123410000810, 123410000811, 123410000812, 123450000535, 123450000536, 123450000537, 123450000538, 123450000539, 123450000540, 123400005838, 123480000403, 123480000404, 123480000405, 123480000406, 123480000407, 123480000408, 123480000409, 123480000410, 123480000411, 123480000412, 124030000221, 124030000222, 124030000223, 124030000720, 124030000721, 124040000748, 124040000749, 124040000750, 124040000751, 124040000752, 124050001632, 124050001633, 124070000341, 124070000342, 124070000343, 124070000344, 124080001389, 124080001390, 124080001391, 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, 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124060000797, 120240001137, 120240001157, 121150000345, 124160001011, 124160001012, 124160002115, 124160002116, 124160002117, 124190000639, 124190001210, 124190001211, 124260000630, 124260000631, 124260000632, 124260000633, 124290000159, 124290002125, 124310000385, 124310000386, 124310000387, 124310002758, 124310002759, 124310002760, 10081765502261100, 10081765502261100, 124090001025, 124090001026, 124100001968, 124100001969, 124140001142, 124160001011, 124160001012, 124160001013,
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Baxter Healthcare Corporation
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer

Product Codes/Lot Numbers:

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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122500000629, 122520000316, 122520000317, 122520000318, 122520000319, 122520000320, 122520000321, 122520000322, 122520000323, 122520000324, 122520000325, 123040001202, 123040001203, 123040001204, 123040001205, 123040001206, 123080000047, 123080000048, 123080000049, 123080000050, 123080000051, 123130002245, 123130002246, 123130002247, 123130002248, 123130002249, 123170000104, 123170000105, 123180001889, 123180001890, 123180001891, 123180001892, 123180001893, 123280000084, 123280000085, 123280000086, 123280000087, UNKNOWN, 123330000948, 123330000949, 123330000950, 123330000951, 123330000952, 123350000803, 123350000804, 123350000805, 123350000806, 123350000807, 123360001860, 123360001861, 123360001862, 123360001863, 123360001864, 123370001189, 123370001190, 123370001191, 123370001192, 123370001193, 123370001194, 123370001195, 123370001196, 123370001197, 123370001198, 123400001281, 123400001282, 123400001283, 123500002178, 123500002179, 124010000233, 124010000234, 124060000797, 120240001137, 120240001157, 121150000345, 124160001011, 124160001012, 124160002115, 124160002116, 124160002117, 124190000639, 124190001210, 124190001211, 124260000630, 124260000631, 124260000632, 124260000633, 124290000159, 124290002125, 124310000385, 124310000386, 124310000387, 124310002758, 124310002759, 124310002760, 10081765502261100, 10081765502261100, 124090001025, 124090001026, 124100001968, 124100001969, 124140001142, 124160001011, 124160001012, 124160001013,

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0324-2025

Related Recalls

Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.

Sep 17, 2025 Diagnostic Equipment Nationwide View Details →