FDAClass IIAugust 29, 2018

EasyDiagnost Eleva DRF recall

EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

Why was EasyDiagnost Eleva DRF recalled?

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

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: 470350/SN10000103 482735/SN11000053 475222/SN11000013 486215/SN11000104 484559/SN11000063 77124552 499144/SN12000035 502428/SN12000048 505693/SN12000054

Product
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
Recalling firm
Philips Medical Systems Gmbh, DMC
Distribution
US Nationwide; International to 66 countries
Recall date
August 29, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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