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Oec elite and oec mobile c-arms

Official notice

18 Dec 2024

Last checked

18 Dec 2024

Medium riskHealth Canada

An official Health Canada notice concerns Oec elite and oec mobile c-arms. GE Healthcare has become aware that recently manufactured OEC Elite and OEC Mobile C-arms, as well as recently replaced x-ray tubes on certain OEC Elite, OEC 3D and OEC 9900/9800 Mobile C-arms potentially have insufficient sealing that can result in an oil leak. This issue could result in loss of fluoroscopic imaging capability. Recall start date: December 5, 2024 Published 2024-12-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76718

Official notice

2024-12-18

The hazard

GE Healthcare has become aware that recently manufactured OEC Elite and OEC Mobile C-arms, as well as recently replaced x-ray tubes on certain OEC Elite, OEC 3D and OEC 9900/9800 Mobile C-arms potentially have insufficient sealing that can result in an oil leak. This issue could result in loss of fluoroscopic imaging capability. Recall start date: December 5, 2024

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.

Recall Numbers

76718

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Affected products

Product 1

Affected products - GE OEC Elite, Lot or serial number - FAXXTE01158 FBXXTE02995, Model or catalog number - OEC ELITE

Risk / hazard

GE Healthcare has become aware that recently manufactured OEC Elite and OEC Mobile C-arms, as well as recently replaced x-ray tubes on certain OEC Elite, OEC 3D and OEC 9900/9800 Mobile C-arms potentially have insufficient sealing that can result in an oil leak. This issue could result in loss of fluoroscopic imaging capability. Recall start date: December 5, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: GE Oec Medical, Oec Elite And Oec Mobile C-arms.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76718

Classification

Type 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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