CanadaThe Philips Zenition 50 fluoroscopy system (model/catalogue number 718096) is affected; lot/serial number not applicable. A supplier-reported contamination in the bonding layer of chips on the image intensifier TV PCBA can corrode bonds, potentially causing intermittent or permanent connection loss and resulting in loss of imaging or clinically unusable images (blurred or reduced image size). Contact the manufacturer for additional information.
What's being recalled
Companies: Philips Medical Systems Nederland B.V., Veenpluis 6, Best, Netherlands, 5684 PC.
How to identify it
Affected products: Zenition 50; Lot or serial number: Not applicable.; Model or catalogue number: 718096
The hazard
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).
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)