Fresh Recalls

FDAClass II · Medical device · Recall Z-3155-2026 · Recalled October 7, 2026

Philips Medical Systems Technologies Ltd recall — Philips North America Llc

Agency report date: October 7, 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 Medical Systems Technologies Ltd
Company / brand
Philips North America
Lot / serial / date codes
UDI: (01)00884838101111
Distribution
U.S. and U.S. Territories.
Agency product description and boundaries

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

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 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.

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 Medical Systems Technologies Ltd recall status

3. Open the official notice or contact

Official recall ID
Z-3155-2026
Brand
All Philips North America recalls
Classification
Class II
Units affected
62
Recall status
Ongoing
Initiated
FDA Mandated

Affected products

Companies & origin

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

Identifying details (verbatim from the notice)

Product codes / lots
UDI: (01)00884838101111
Distribution
U.S. and U.S. Territories.
FDA event ID
99865
Recall initiated
August 18, 2026
FDA classified
September 29, 2026
FDA report date
October 7, 2026

Other medical device recalls from around the same time

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 October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

Report a data error on this page