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Brainlab - safety alert

Official notice

16 Mar 2022

MediumFDA

An official FDA notice concerns Brainlab. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2022-03-16. Recall numbers: Z-0733-2022. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

205

Recall number

Z-0733-2022

Official notice

2022-03-16

The hazard

Health risk requiring medical assessment

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

89662

Recall Numbers

Z-0733-2022

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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 · AR

Location 2

US · United States · AZ

Location 3

US · United States · CA

Location 4

US · United States · CO

Location 5

US · United States · FL

Location 6

US · United States · GA

Location 7

US · United States · IN

Location 8

US · United States · KY

Location 9

US · United States · MD

Location 10

US · United States · MO

Location 11

US · United States · MS

Location 12

US · United States · NC

Location 13

US · United States · NJ

Location 14

US · United States · NY

Location 15

US · United States · OK

Location 16

US · United States · OR

Location 17

US · United States · PA

Location 18

US · United States · TX

Location 19

US · United States · VA

Location 20

US · United States · WA

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

CN · China

Affected area 7

DE · Germany

Affected area 8

DK · Denmark

Affected area 9

ES · Spain

Affected area 10

FR · France

Affected area 11

GB · United Kingdom

Affected area 12

HK · Hong Kong

Affected area 13

IE · Ireland

Affected area 14

IL · Israel

Affected area 15

IN · India

Affected area 16

IT · Italy

Affected area 17

JO · Jordan

Affected area 18

JP · Japan

Affected area 19

KR · South Korea

Affected area 20

NZ · New Zealand

Affected area 21

PL · Poland

Affected area 22

SG · Singapore

Affected area 23

SK · Slovakia

Affected area 24

TH · Thailand

Affected area 25

TR · Turkey

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-0733-2022

Event id

89662

Units affected

205

Status

active

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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