OVERLOOKED

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Class IIOngoing

Philips North America Llc recalls Philips Medical Systems Technologies Ltd

Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as fda mandated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Philips North America Llc
Reason
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
U.S. and U.S. Territories.
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99865…

Products

  1. Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

    Codes/lots: UDI: (01)00884838101111Quantity: 62Recall no. Z-3155-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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