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Brainlab - safety alert

Official notice

21 Jan 2015

MediumFDA

An official FDA notice concerns Brainlab. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2015-01-21. Recall numbers: Z-0956-2015. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,412

Recall number

Z-0956-2015

Official notice

2015-01-21

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

69960

Recall Numbers

Z-0956-2015

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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 · AL

Location 2

US · United States · AR

Location 3

US · United States · AZ

Location 4

US · United States · CA

Location 5

US · United States · CO

Location 6

US · United States · CT

Location 7

US · United States · FL

Location 8

US · United States · GA

Location 9

US · United States · IA

Location 10

US · United States · ID

Location 11

US · United States · IL

Location 12

US · United States · IN

Location 13

US · United States · KS

Location 14

US · United States · KY

Location 15

US · United States · LA

Location 16

US · United States · MA

Location 17

US · United States · MD

Location 18

US · United States · ME

Location 19

US · United States · MI

Location 20

US · United States · MN

Location 21

US · United States · MO

Location 22

US · United States · MS

Location 23

US · United States · MT

Location 24

US · United States · NC

Location 25

US · United States · ND

Location 26

US · United States · NE

Location 27

US · United States · NH

Location 28

US · United States · NJ

Location 29

US · United States · NV

Location 30

US · United States · NY

Location 31

US · United States · OH

Location 32

US · United States · OK

Location 33

US · United States · OR

Location 34

US · United States · PA

Location 35

US · United States · RI

Location 36

US · United States · SC

Location 37

US · United States · SD

Location 38

US · United States · TN

Location 39

US · United States · TX

Location 40

US · United States · UT

Location 41

US · United States · VA

Location 42

US · United States · VT

Location 43

US · United States · WA

Location 44

US · United States · WI

Location 45

US · United States · WY

Affected area 1

US · United States

Affected area 2

AR · Argentina

Affected area 3

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BE · Belgium

Affected area 6

BR · Brazil

Affected area 7

CA · Canada

Affected area 8

CH · Switzerland

Affected area 9

CL · Chile

Affected area 10

CN · China

Affected area 11

CO · Colombia

Affected area 12

CZ · Czech Republic

Affected area 13

DE · Germany

Affected area 14

DK · Denmark

Affected area 15

DO · Dominican Republic

Affected area 16

ES · Spain

Affected area 17

FI · Finland

Affected area 18

FR · France

Affected area 19

GB · United Kingdom

Affected area 20

GR · Greece

Affected area 21

HK · Hong Kong

Affected area 22

HU · Hungary

Affected area 23

IE · Ireland

Affected area 24

IL · Israel

Affected area 25

IN · India

Affected area 26

IT · Italy

Affected area 27

JP · Japan

Affected area 28

KR · South Korea

Affected area 29

LT · Lithuania

Affected area 30

LV · Latvia

Affected area 31

MX · Mexico

Affected area 32

MY · Malaysia

Affected area 33

NL · Netherlands

Affected area 34

NO · Norway

Affected area 35

PL · Poland

Affected area 36

PT · Portugal

Affected area 37

RO · Romania

Affected area 38

SA · Saudi Arabia

Affected area 39

SE · Sweden

Affected area 40

SG · Singapore

Affected area 41

SI · Slovenia

Affected area 42

TH · Thailand

Affected area 43

TR · Turkey

Affected area 44

TW · Taiwan

Affected area 45

UA · Ukraine

Affected area 46

UY · Uruguay

Affected area 47

VE · Venezuela

Affected area 48

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-0956-2015

Event id

69960

Units affected

1,412

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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