FDAClass IINovember 30, 2016

Philips Healthcare System X-ray Tomography Computed recall

Philips Healthcare System X-ray Tomography Computed :

Why was Philips Healthcare System X-ray Tomography Computed recalled?

It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

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?

Brilliance iCT SP, Brilliance iCT, Brilliance 64, Brilliance 40, Brilliance 16, Brilliance 16P, Brilliance 10, Brilliance 6, Brilliance Big Bore.

Product
Philips Healthcare System X-ray Tomography Computed :
Recalling firm
Philips Electronics North America Corporation
Quantity
1363
Distribution
USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.
Recall date
November 30, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls