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Brainlab - safety alert

Official notice

1 May 2019

MediumFDA

An official FDA notice concerns Brainlab. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2019-05-01. Recall numbers: Z-1205-2019. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

164

Recall number

Z-1205-2019

Official notice

2019-05-01

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

82601

Recall Numbers

Z-1205-2019

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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

CN · China

Affected area 11

CO · Colombia

Affected area 12

DE · Germany

Affected area 13

ES · Spain

Affected area 14

FI · Finland

Affected area 15

FR · France

Affected area 16

GB · United Kingdom

Affected area 17

HK · Hong Kong

Affected area 18

IE · Ireland

Affected area 19

IL · Israel

Affected area 20

IT · Italy

Affected area 21

JO · Jordan

Affected area 22

JP · Japan

Affected area 23

KR · South Korea

Affected area 24

MX · Mexico

Affected area 25

NL · Netherlands

Affected area 26

PL · Poland

Affected area 27

PT · Portugal

Affected area 28

SV · El Salvador

Affected area 29

TW · Taiwan

Affected area 30

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-1205-2019

Event id

82601

Units affected

164

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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