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MINI Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system - safety alert

Official notice

11 Jan 2023

MediumFDA

An official FDA notice concerns Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-01-11. Recall numbers: Z-0776-2023. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

3,235

Recall number

Z-0776-2023

Official notice

2023-01-11

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

91260

Recall Numbers

Z-0776-2023

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Affected products

Product 1

Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

Units affected

3,235

Risk / hazard

Health risk requiring medical assessment

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

BE · Belgium

Affected area 5

CH · Switzerland

Affected area 6

CL · Chile

Affected area 7

CO · Colombia

Affected area 8

CZ · Czech Republic

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

GR · Greece

Affected area 16

HK · Hong Kong

Affected area 17

HU · Hungary

Affected area 18

IE · Ireland

Affected area 19

IL · Israel

Affected area 20

IN · India

Affected area 21

IS · Iceland

Affected area 22

IT · Italy

Affected area 23

KW · Kuwait

Affected area 24

LU · Luxembourg

Affected area 25

NL · Netherlands

Affected area 26

NO · Norway

Affected area 27

NZ · New Zealand

Affected area 28

PL · Poland

Affected area 29

PT · Portugal

Affected area 30

RO · Romania

Affected area 31

RS · Serbia

Affected area 32

SA · Saudi Arabia

Affected area 33

SE · Sweden

Affected area 34

SI · Slovenia

Affected area 35

SK · Slovakia

Affected area 36

TR · Turkey

Affected area 37

UA · Ukraine

Affected area 38

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: MINI, Medtronic Minimed. Contact: Medtronic MiniMed.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0776-2023

Event id

91260

Units affected

3,235

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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