FDAClass IIFebruary 1, 2017

Allura Xper FD20 722012 is intended for: Cardiovascular recall

Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such…

Why was Allura Xper FD20 722012 is intended for: Cardiovascular recalled?

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

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?

2786

Product
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such…
Recalling firm
Philips Electronics North America Corporation
Quantity
1
Distribution
US: WA OUS: China, Spain, Korea, Republic of, Germany
Recall date
February 1, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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