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Mobile Diagnostic X-Ray System with Digital Panel

FDA Recall #Z-1706-2017 — Class II — November 28, 2012

Recall #Z-1706-2017 Date: November 28, 2012 Classification: Class II Status: Terminated

Product Description

Mobile Diagnostic X-Ray System with Digital Panel

Reason for Recall

When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.

Recalling Firm

Philips Healthcare Inc. — Andover, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

220 systems

Distribution

Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)

Code Information

*** All units ***

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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