FDA · Class II · October 7, 2026

Philips recall: Medical Systems Technologies Ltd

Philips North America Llc is recalling Philips Medical Systems Technologies Ltd because of an increased risk of a crash – 62. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on August 18, 2026. Distributed U.S. and U.S. Territories..

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

An FDA laboratory that tests medical devices
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
ProductPhilips Medical Systems Technologies Ltd
BrandPhilips
CompanyPhilips North America Llc
TypeMedical devices
ClassificationClass II
Recall dateAugust 18, 2026
Published by FDAOctober 7, 2026
Quantity62
Recall ID99865
As listed by FDA

Recalled products

  1. Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
    FDA recall number
    Z-3155-2026
    Codes, lots and dates
    UDI: (01)00884838101111
    Quantity
    62
    Classification
    Class II
Exactly as the agency lists them

Identifiers and details

FDA event ID
99865
Initiated
FDA Mandated
Status
Ongoing
Firm location
Cambridge, MA, United States

Why it was recalled

The problem: an increased risk of a crash.

The reason the FDA lists: “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.”

Where it was sold

Distribution as the FDA records it: “U.S. and U.S. Territories.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99865, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Same brand

Other Philips recalls

DateRecallProblemAgency
Oct 7, 2026Philips recall: Ingenia Blue Seal SE and Blue Seal XE and 11 more productsMedical devices · 6; 216; 243; 422; 340; 131; 107; 200; 5; 1; 30; 91When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR…
Serious
FDA
Class II
Sep 30, 2026Philips recall: Achieva 1.5T and 11 more productsMedical devices · 387; 210; 15; 91; 2038; 922; 1447; 596; 82; 611; 37; 965A software issue will terminate an examination during the image reconstruction process if …
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Sep 23, 2026Philips recall: Patient Information Center iX REF:866389 and 1 more productMedical devices · 7359 Units; 312 unitsDue to software malfunction, patient information system may freeze and become unresponsive…
Serious
FDA
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Sep 9, 2026Philips recall: Brilliance and 3 more productsMedical devices · N/APhilips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity…
Serious
FDA
Class II
Aug 26, 2026Philips recall: Cardiac Workstation 5000 and 1 more productMedical devices · 796 units; 1,810 unitsDevice will intermittently provide inaccurate data related to native heart rate.
Serious
FDA
Class II

All 6 Philips recalls →

FAQ

About this recall

Is Philips Philips Medical Systems Technologies Ltd recalled?

Yes. Philips North America Llc recalled it on August 18, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Because of an increased risk of a crash. The reason given: 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.

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

U.S. and U.S. Territories..

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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