FDAClass IIDecember 11, 2013

Easy Diagnost Eleva Universal Fluoroscopic applications recall: Software Issue

Easy Diagnost Eleva Universal Fluoroscopic applications

Why was Easy Diagnost Eleva Universal Fluoroscopic applications recalled?

The delivered application software was an outdated version to the model of equipment.

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?

706050, 706083, 706088

Product
Easy Diagnost Eleva Universal Fluoroscopic applications
Recalling firm
Philips Medical Systems, Inc.
Quantity
19 devices
Distribution
Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
Recall date
December 11, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls