Recall Monitor
Health Products

SIGNA™ Artist and SIGNA™ Artist Evo

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: SIGNA™ Artist and SIGNA™ Artist Evo
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
SIGNA™ ArtistPGRART2500010SIGNA ARTIST
SIGNA™ Artist EvoIPGEV2400062SC00195278481382
SIGNA™ Artist EvoIPGEVO250000800195278481382
SIGNA™ Artist EvoIPGEV2400132SC00195278481382
SIGNA™ Artist EvoIPGEV2500201SC00195278481382
SIGNA™ Artist EvoIPGEV2400103SC00195278481382
SIGNA™ Artist EvoIPGEV2400090SC00195278481382
SIGNA™ Artist EvoIPGEV2400110SC00195278481382
SIGNA™ Artist EvoIPGEV2500222SC00195278481382
SIGNA™ Artist EvoIPGEV2400083SC00195278481382

Issue

GE Healthcare has become aware of an exposed sharp edge inside the SIGNA™ Artist Evo and SIGNA™ Artist electronics cabinet that could damage power cables, which may potentially cause an electrical fault. If the electrical fault is present and the cabinet door is opened while the system is powered, this could potentially result in an arc flash that could lead to serious injury to service personnel in immediate proximity.

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