Recall Monitor
Health Products

Zenition 50

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Zenition 50
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
Zenition 50Not applicable.718096

Issue

Philips has been notified by a supplier about an issue affecting integrated chips used in the image intensifier television (IITV) of the Zenition 50 systems. Due to contamination in the bonding layer of the chips on the PCBA (printed circuit board assembly) there could be corrosion of the bonding layer, potentially resulting in intermittent or permanent connection loss of the integrated chips. The issue may result in loss of imaging functionality, or clinically unusable images due to reduced image quality (blurred, reduced image size).

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