Fresh Recalls

FDAClass II · Medical device · Recall Z-2650-2026 · Recalled August 5, 2026

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 B recall — PHILIPS MEDICAL SYSTEMS

Agency report date: August 5, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 B
Company / brand
PHILIPS MEDICAL SYSTEMS
Lot / serial / date codes
FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232
Distribution
US Nationwide Distribution including Puerto Rico
Agency product description and boundaries

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 B

3. Open the official notice or contact

Official recall ID
Z-2650-2026
Brand
PHILIPS MEDICAL SYSTEMS
Classification
Class II
Units affected
128
Recall status
Ongoing
Initiated
FDA Mandated

Affected products

Companies & origin

Recalling firm location
Cambridge, MA, United States
Firm address
222 Jacobs St, N/A, 02141-2289

Identifying details (verbatim from the notice)

Product codes / lots
FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232
Distribution
US Nationwide Distribution including Puerto Rico
Firm notified the public via
Letter
FDA event ID
99352
Recall initiated
June 11, 2026
FDA classified
July 27, 2026
FDA report date
August 5, 2026
Verify with the official sources:

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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