FDAClass IIDecember 9, 2015

Patient Support Material Number: 9890 010 87431 recall

Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050

Why was Patient Support Material Number: 9890 010 87431 recalled?

The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the 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?

All patient support for stitching are affected.

Product
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Recalling firm
Philips Medical Systems, Inc.
Quantity
260 units, not all units have the patient support accessory
Distribution
Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
Recall date
December 9, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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