FDAClass IIApril 25, 2018

Brilliance 64 with 4.1.7 XX026 software version recall

Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce…

Why was Brilliance 64 with 4.1.7 XX026 software version recalled?

Surview scan with tube current lower than 30 mA is unable to be initialized.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669

Product
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce…
Recalling firm
Philips Medical Systems (Cleveland) Inc
Quantity
291
Distribution
Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
Recall date
April 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls