The Recall Desk

Hazard

Treatment Risk recalls

6 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2026-04-08

Of the 6 treatment risk recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all treatment risk recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–6 of 6

  • HighFDA (Devices)·Z-1656-2026·2026-04-08

    RefleXion X1 may deliver radiotherapy dose to the incorrect location

    RefleXion Medical is recalling the X1 Radiotherapy System because a software defect can mean angular roll corrections are not carried through to treatment delivery.

    Product
    RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1581-2026·2026-03-25

    Leksell Gamma Knife recalled over adapter not properly aligned or locked

    Elekta is recalling Leksell Gamma Knife radiosurgery systems, covering the Perfexion, Icon and Elekta Esprit models, due to an adapter not being properly aligned or locked in place.

    Product
    Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2022·2022-09-07

    RT-PCR Kit Recalled Due to False Positive Test Results

    Qiagen's FGFR RGQ RT-PCR Kit may produce false positive results, leading to incorrect lab reports. This could expose cancer patients to inappropriate or suboptimal treatment.

    Product
    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0885-2022·2022-04-13

    SyncVision Systems cardiac imaging measurement error in same-session workflow

    SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.

    Product
    SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0200-2022·2021-11-10

    Artis zeego X-Ray System Software Error Affects Image Reconstruction

    Siemens Artis zeego fluoroscopic X-ray systems have a software error that incorrectly displays 3D image reconstruction when the patient table is rotated more than 4 degrees, potentially resulting in incorrect patient treatment during image-guided procedures.

    Product
    Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2022·2021-10-20

    Cobas EGFR Mutation Test v2 may return false mutation detection results

    The cobas EGFR Mutation Test v2 may produce false positive results for exon 20 insertion mutations, potentially leading to inappropriate treatment. Healthcare providers should verify detected mutations using alternative methods.

    Product
    cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
    Category
    Medical Device
    Distribution
    Distributed nationwide