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Brainlab - safety alert

Official notice

27 Jan 2016

CriticalFDA

An official FDA notice concerns Brainlab. The notice reports a serious safety risk. Follow the official notice for consumer instructions. Published 2016-01-27. Recall numbers: Z-0598-2016. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

2,528

Recall number

Z-0598-2016

Official notice

2016-01-27

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

71924

Recall Numbers

Z-0598-2016

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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

AR · Argentina

Affected area 4

AT · Austria

Affected area 5

AU · Australia

Affected area 6

BE · Belgium

Affected area 7

BR · Brazil

Affected area 8

CA · Canada

Affected area 9

CH · Switzerland

Affected area 10

CL · Chile

Affected area 11

CN · China

Affected area 12

CO · Colombia

Affected area 13

CZ · Czech Republic

Affected area 14

DE · Germany

Affected area 15

DK · Denmark

Affected area 16

DO · Dominican Republic

Affected area 17

EE · Estonia

Affected area 18

EG · Egypt

Affected area 19

ES · Spain

Affected area 20

FI · Finland

Affected area 21

FR · France

Affected area 22

GB · United Kingdom

Affected area 23

GR · Greece

Affected area 24

HK · Hong Kong

Affected area 25

HU · Hungary

Affected area 26

IE · Ireland

Affected area 27

IL · Israel

Affected area 28

IN · India

Affected area 29

IT · Italy

Affected area 30

JO · Jordan

Affected area 31

JP · Japan

Affected area 32

KR · South Korea

Affected area 33

LT · Lithuania

Affected area 34

LV · Latvia

Affected area 35

MX · Mexico

Affected area 36

MY · Malaysia

Affected area 37

NL · Netherlands

Affected area 38

NO · Norway

Affected area 39

PK · Pakistan

Affected area 40

PL · Poland

Affected area 41

PT · Portugal

Affected area 42

SA · Saudi Arabia

Affected area 43

SE · Sweden

Affected area 44

SG · Singapore

Affected area 45

SI · Slovenia

Affected area 46

SK · Slovakia

Affected area 47

TH · Thailand

Affected area 48

TR · Turkey

Affected area 49

TW · Taiwan

Affected area 50

UA · Ukraine

Affected area 51

VE · Venezuela

Affected area 52

VN · Vietnam

Affected area 53

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Brainlab. Contact: Brainlab AG.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class I

App estimate

critical

Recall details

Recall number

Z-0598-2016

Event id

71924

Units affected

2,528

Status

terminated

Classification

Class I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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