FDAClass IIFebruary 13, 2013

Phillips Easy Diagnost Eleva DRF recall

Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications

Why was Phillips Easy Diagnost Eleva DRF recalled?

The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.

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 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409

Product
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
Recalling firm
Philips Healthcare Inc.
Quantity
14 units
Distribution
US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.
Recall date
February 13, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls