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Brainlab - safety alert

Official notice

30 Sept 2015

MediumFDA

An official FDA notice concerns Brainlab. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2015-09-30. Lots: 1014213001. Models: 41773G. Recall numbers: Z-2795-2015. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

28

Recall number

Z-2795-2015

Official notice

2015-09-30

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.

Lots

1014213001

Skus

41773G

Event Ids

71996

Model Numbers

41773G

Recall Numbers

Z-2795-2015

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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

AU · Australia

Affected area 5

BR · Brazil

Affected area 6

CH · Switzerland

Affected area 7

CL · Chile

Affected area 8

CN · China

Affected area 9

CO · Colombia

Affected area 10

CZ · Czech Republic

Affected area 11

DE · Germany

Affected area 12

DK · Denmark

Affected area 13

DO · Dominican Republic

Affected area 14

EG · Egypt

Affected area 15

FI · Finland

Affected area 16

FR · France

Affected area 17

GB · United Kingdom

Affected area 18

HK · Hong Kong

Affected area 19

HU · Hungary

Affected area 20

IE · Ireland

Affected area 21

IL · Israel

Affected area 22

IN · India

Affected area 23

IT · Italy

Affected area 24

JP · Japan

Affected area 25

KR · South Korea

Affected area 26

KW · Kuwait

Affected area 27

LT · Lithuania

Affected area 28

MT · Malta

Affected area 29

MX · Mexico

Affected area 30

MY · Malaysia

Affected area 31

NL · Netherlands

Affected area 32

PL · Poland

Affected area 33

PT · Portugal

Affected area 34

SA · Saudi Arabia

Affected area 35

SG · Singapore

Affected area 36

SI · Slovenia

Affected area 37

SV · El Salvador

Affected area 38

TH · Thailand

Affected area 39

TR · Turkey

Affected area 40

TW · Taiwan

Affected area 41

UA · Ukraine

Affected area 42

VE · Venezuela

Affected area 43

VN · Vietnam

Affected area 44

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 II

App estimate

medium

Recall details

Recall number

Z-2795-2015

Event id

71996

Units affected

28

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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