Bunkerhill AVC

Validation studies (1)

Reported performance (2 observations)

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

• re_clearance

  The FDA AI/ML device list shows a newer 510(k) K260167 (decision 2026-03-06) from BunkerHill Health for a matching device line ("Bunkerhill Contrast AVC") — a new clearance for the same line is a change event.

  first seen 2026-07-08 · k_number:K260167

• recall_reason_pattern

  Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:98738

• recall_reason_pattern

  Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:98588

• recall_reason_pattern

  Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:98206

• recall_reason_pattern

  Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:97699

• recall_reason_pattern

  Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:97010

• …and 4 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.