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Brainlab - safety alert

Official notice

14 Oct 2020

MediumFDA

An official FDA notice concerns Brainlab. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2020-10-14. Recall numbers: Z-0056-2021. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

271

Recall number

Z-0056-2021

Official notice

2020-10-14

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

86438

Recall Numbers

Z-0056-2021

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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

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

CZ · Czech Republic

Affected area 10

DE · Germany

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

HK · Hong Kong

Affected area 17

IL · Israel

Affected area 18

IN · India

Affected area 19

IT · Italy

Affected area 20

JP · Japan

Affected area 21

KW · Kuwait

Affected area 22

MY · Malaysia

Affected area 23

NL · Netherlands

Affected area 24

NO · Norway

Affected area 25

PK · Pakistan

Affected area 26

RO · Romania

Affected area 27

SE · Sweden

Affected area 28

SK · Slovakia

Affected area 29

TH · Thailand

Affected area 30

TR · Turkey

Affected area 31

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-0056-2021

Event id

86438

Units affected

271

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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