The Recall Desk

Hazard

Dark Image recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2026-06-10

Of the 2 dark image 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 dark image 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.

1–2 of 2

  • HighFDA (Devices)·Z-2289-2026·2026-06-10

    Philips Azurion 7B20/15 systems may show unusable dark fluoroscopy images

    Philips Azurion 7B20/15 systems with the Roadmap Pro software key are being recalled because a pedal tap may produce a dark image that is not clinically usable. 156 units affected.

    Product
    Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2026·2026-06-10

    Philips Azurion 5M12 systems may show unusable dark fluoroscopy images

    Philips Azurion 5M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may produce a dark image that is not clinically usable.

    Product
    Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
    Category
    Medical Device
    Distribution
    Distributed nationwide