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Recall Observatory FDA recall evidence

Device product

Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

Z-1253-2025

February 05, 2025

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 96289
Status
Ongoing
Classification
Class I
Quantity
66 units
Official record key
device-enforcement:Z-1253-2025

Official wording

Reason: There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

Code information: UDI/DI 00085412091570, Serial Numbers: 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302, 775486, 778837, 785425, 793453, 795240, 798065, 814485, 818850, 826637, 850214, 850854, 851500, 854157, 855803, 863354, 870307, 873114, 876483, 877014, 877102, 889153, 896292, 900181, 906422, 907176, 912242, 913562, 927864, 938265, 958176, 962828, 963975, 965158, 974676, 981605, 982459, 984154, 986132, 986634, 989053, 993087, 994417, 994842, 995538, 997153, 1006359, 1011058, 1013925, 1014064, 1014529, 1014856, 1017150, 1017546, 1018229, 1018703, 1024109

Distribution pattern: US: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is the potential for missing motor mounting screws, which may have occurred during the servicing process.