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Brainlab - safety alert

Official notice

6 Aug 2014

MediumFDA

An official FDA notice concerns Brainlab. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2014-08-06. Models: 25100-05. Recall numbers: Z-2134-2014. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

154

Recall number

Z-2134-2014

Official notice

2014-08-06

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.

Skus

25100-05

Event Ids

68737

Model Numbers

25100-05

Recall Numbers

Z-2134-2014

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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

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BE · Belgium

Affected area 6

BR · Brazil

Affected area 7

CH · Switzerland

Affected area 8

CL · Chile

Affected area 9

CN · China

Affected area 10

DE · Germany

Affected area 11

ES · Spain

Affected area 12

FR · France

Affected area 13

GB · United Kingdom

Affected area 14

JP · Japan

Affected area 15

NL · Netherlands

Affected area 16

NO · Norway

Affected area 17

NZ · New Zealand

Affected area 18

RU · Russia

Affected area 19

TW · Taiwan

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-2134-2014

Event id

68737

Units affected

154

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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