FDAClass II · Medical device · Recall Z-2988-2026 · Recalled September 2, 2026

Philips Incisive CT with software V4 recall — Philips Healthcare (Suzhou) Co., Ltd.

Agency report date: September 2, 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: Philips Incisive CT with software V4
Company / brand: Philips Healthcare (Suzhou) Co
Lot / serial / date codes: Device Identifier: (01)00884838085015, (01)00884838105508.
Distribution: U.S. Nationwide and U.S. Territories distribution.

Agency product description and boundaries

Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.

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: Potential of failing to trigger clinical scan during Bolus Tracking.

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: Philips Incisive CT with software V4 recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2988-2026
Brand: All Philips Healthcare (Suzhou) Co recalls
Classification: Class II
Units affected: N/A
Recall status: Ongoing
Initiated: FDA Mandated

Affected products

Philips Incisive CT with software V4 recall status

Companies & origin

Recalling firm location: Suzhou, N/A, China
Firm address: Suzhou Industrial Park, No. 258 Zhongyuan Road; Pingjiang, N/A

Identifying details (verbatim from the notice)

Product codes / lots: Device Identifier: (01)00884838085015, (01)00884838105508.
Distribution: U.S. Nationwide and U.S. Territories distribution.
Firm notified the public via: N/A
FDA event ID: 99511
Recall initiated: June 26, 2026
FDA classified: August 21, 2026
FDA report date: September 2, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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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 October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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