The Recall Desk

FDA (Devices) recall action 82743

Angiodynamics Inc. (Navilyst Medical Inc.) recalled 5 products on 2019-06-12

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2019-06-12
Critical
0
Units
20,266

Why these products were recalled

Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • HighFDA (Devices)··2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures

    AngioDynamics is recalling 178 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
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    0 states
  • HighFDA (Devices)··2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedure Risk

    AngioDynamics is recalling Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from delayed procedures via manual and software updates.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue…
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    0 states
  • HighFDA (Devices)··2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures

    AngioDynamics is recalling 314 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L…
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    0 states
  • HighFDA (Devices)··2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Procedure Delay Risk

    AngioDynamics is recalling 1,846 Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue…
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    0 states
  • HighFDA (Devices)··2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures

    AngioDynamics is recalling 7,348 Solero Microwave Tissue Ablation applicators to update manuals and software, reducing the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue…
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    0 states