Health product recall

Zenition 50

Last updated

Summary

Product
Zenition 50
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Zenition 50 Not 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).

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78297

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