FDAClass IIJune 27, 2012

Philips Easy Diagnost Product Usage: Stationary recall

Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

Why was Philips Easy Diagnost Product Usage: Stationary recalled?

If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut

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 systems with Eleva software version 4.x and stitching option.

Product
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
Recalling firm
Philips Healthcare Inc.
Quantity
6
Distribution
6 US customers
Recall date
June 27, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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