FDAClass IIApril 12, 2017

Mobile Diagnostic X-Ray System with Digital Panel recall

Mobile Diagnostic X-Ray System with Digital Panel

Why was Mobile Diagnostic X-Ray System with Digital Panel recalled?

When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.

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?

*** All units ***

Product
Mobile Diagnostic X-Ray System with Digital Panel
Recalling firm
Philips Healthcare Inc.
Quantity
220 systems
Distribution
Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
Recall date
April 12, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls