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No image published for this recall

Fujifilm Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage - safety alert

Official notice

8 Jun 2016

Last checked

8 Jun 2016

Medium riskFDA

An official FDA notice concerns Fujifilm Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage - safety alert. An official FDA notice concerns Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage. The notice reports an infection risk. Follow the official notice for consumer instructions. Published 2016-06-08. Recall numbers: Z-1863-2016. Check the official notice for the complete list. Published 2016-06-08.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

484

Recall number

Z-1863-2016

Official notice

2016-06-08

The hazard

An official FDA notice concerns Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage. The notice reports an infection risk. Follow the official notice for consumer instructions. Published 2016-06-08. Recall numbers: Z-1863-2016. Check the official notice for the complete list.

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

73469

Recall Numbers

Z-1863-2016

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Affected products

Product 1

Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage

Units affected

484

Risk / hazard

An official FDA notice concerns Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage. The notice reports an infection risk. Follow the official notice for consumer instructions. Published 2016-06-08. Recall numbers: Z-1863-2016. Check the official notice for the complete list.

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 · NJ · Wayne

Affected area 1

US · United States · NJ · Wayne

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Fujifilm. Contact: Fujifilm Medical Systems U.S.A., Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-1863-2016

Event id

73469

Units affected

484

Status

terminated

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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