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Brainlab - safety alert

Official notice

2 Sept 2015

MediumFDA

An official FDA notice concerns Brainlab. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2015-09-02. Recall numbers: Z-2440-2015. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

361

Recall number

Z-2440-2015

Official notice

2015-09-02

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

71898

Recall Numbers

Z-2440-2015

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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 · AK

Location 2

US · United States · AL

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 · ID

Location 10

US · United States · IL

Location 11

US · United States · IN

Location 12

US · United States · KY

Location 13

US · United States · LA

Location 14

US · United States · MA

Location 15

US · United States · MD

Location 16

US · United States · MI

Location 17

US · United States · MN

Location 18

US · United States · NC

Location 19

US · United States · ND

Location 20

US · United States · NE

Location 21

US · United States · NY

Location 22

US · United States · OH

Location 23

US · United States · OK

Location 24

US · United States · OR

Location 25

US · United States · PA

Location 26

US · United States · RI

Location 27

US · United States · SC

Location 28

US · United States · TN

Location 29

US · United States · TX

Location 30

US · United States · VA

Location 31

US · United States · WA

Location 32

US · United States · WI

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

AU · Australia

Affected area 4

BE · Belgium

Affected area 5

BR · Brazil

Affected area 6

CA · Canada

Affected area 7

CH · Switzerland

Affected area 8

CN · China

Affected area 9

DE · Germany

Affected area 10

DK · Denmark

Affected area 11

ES · Spain

Affected area 12

FI · Finland

Affected area 13

FR · France

Affected area 14

GB · United Kingdom

Affected area 15

HK · Hong Kong

Affected area 16

IL · Israel

Affected area 17

IN · India

Affected area 18

IT · Italy

Affected area 19

JP · Japan

Affected area 20

KR · South Korea

Affected area 21

NL · Netherlands

Affected area 22

RU · Russia

Affected area 23

SI · Slovenia

Affected area 24

TH · Thailand

Affected area 25

TR · Turkey

Affected area 26

TW · Taiwan

Affected area 27

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-2440-2015

Event id

71898

Units affected

361

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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