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Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333

Official notice

14 Oct 2026

Last checked

20 Oct 2026

MediumFDA

An official FDA notice concerns Philips Medical. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-10-14. Models: 728333, 728340, 728344, 728345. Recall numbers: Z-0078-2027. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

539

Recall number

Z-0078-2027

Official notice

2026-10-14

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

728333, 728340, 728344, 728345

Other

UDI-DI 00884838111103, UDI-DI 00884838117822, UDI-DI 00884838123748

Event Ids

99796

Model Numbers

728333, 728340, 728344, 728345

Recall Numbers

Z-0078-2027

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

AU · Australia

Affected area 4

BE · Belgium

Affected area 5

BG · Bulgaria

Affected area 6

CH · Switzerland

Affected area 7

CN · China

Affected area 8

CZ · Czech Republic

Affected area 9

DE · Germany

Affected area 10

DK · Denmark

Affected area 11

ES · Spain

Affected area 12

FR · France

Affected area 13

GB · United Kingdom

Affected area 14

HK · Hong Kong

Affected area 15

HR · Croatia

Affected area 16

IE · Ireland

Affected area 17

IL · Israel

Affected area 18

IN · India

Affected area 19

IT · Italy

Affected area 20

JO · Jordan

Affected area 21

JP · Japan

Affected area 22

KR · South Korea

Affected area 23

LT · Lithuania

Affected area 24

LV · Latvia

Affected area 25

MX · Mexico

Affected area 26

MY · Malaysia

Affected area 27

NL · Netherlands

Affected area 28

NO · Norway

Affected area 29

NZ · New Zealand

Affected area 30

PL · Poland

Affected area 31

PT · Portugal

Affected area 32

RO · Romania

Affected area 33

SG · Singapore

Affected area 34

SV · El Salvador

Affected area 35

TH · Thailand

Affected area 36

TW · Taiwan

Affected area 37

VN · Vietnam

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Philips Medical. Contact: PHILIPS MEDICAL SYSTEMS.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0078-2027

Event id

99796

Units affected

539

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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