FDAClass IIJune 21, 2017

Philips DigitalDiagnost 3.1.x X-Ray System recall

Philips DigitalDiagnost 3.1.x X-Ray System

Why was Philips DigitalDiagnost 3.1.x X-Ray System recalled?

During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.

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?

DigitalDiagnost Upgrade Release 3.1.x to 3.1.3

Product
Philips DigitalDiagnost 3.1.x X-Ray System
Recalling firm
Philips Electronics North America Corporation
Quantity
US - 132
Distribution
USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls