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GE Medical Information - safety alert

Official notice

7 Feb 2018

MediumFDA

An official FDA notice concerns GE Medical Information. The notice reports a health risk requiring medical assessment. Follow the official notice for consumer instructions. Published 2018-02-07. Recall numbers: Z-0487-2018. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,803

Recall number

Z-0487-2018

Official notice

2018-02-07

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.

Event Ids

78918

Recall Numbers

Z-0487-2018

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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

AE · United Arab Emirates

Affected area 3

AT · Austria

Affected area 4

AU · Australia

Affected area 5

CA · Canada

Affected area 6

CH · Switzerland

Affected area 7

CR · Costa Rica

Affected area 8

CZ · Czech Republic

Affected area 9

DE · Germany

Affected area 10

DK · Denmark

Affected area 11

EG · Egypt

Affected area 12

ES · Spain

Affected area 13

FI · Finland

Affected area 14

FR · France

Affected area 15

GB · United Kingdom

Affected area 16

HU · Hungary

Affected area 17

IE · Ireland

Affected area 18

IN · India

Affected area 19

IS · Iceland

Affected area 20

IT · Italy

Affected area 21

JO · Jordan

Affected area 22

JP · Japan

Affected area 23

KR · South Korea

Affected area 24

KW · Kuwait

Affected area 25

MX · Mexico

Affected area 26

NL · Netherlands

Affected area 27

NO · Norway

Affected area 28

NZ · New Zealand

Affected area 29

PL · Poland

Affected area 30

SA · Saudi Arabia

Affected area 31

SE · Sweden

Affected area 32

SG · Singapore

Affected area 33

SK · Slovakia

Affected area 34

TH · Thailand

Affected area 35

TR · Turkey

Affected area 36

TW · Taiwan

Affected area 37

UY · Uruguay

Affected area 38

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: GE Medical Information. Contact: GE Medical Systems Information Technologies, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0487-2018

Event id

78918

Units affected

1,803

Status

terminated

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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