Philips Medical Systems, Inc. recalls Philips Healthcare DigitalDiagnost System X-Ray

Recall date

February 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1554-2015

FDA classification

Class II

Brand / firm

Philips Medical Systems, Inc.

Sold / distributed

Worldwide Distribution - Nationwide Distribution and the countries of Australia, Austria, Argentina, Canada, China, Chile, Colombia Czech Republic, Great Britain, Germany, Egypt, Finland, France, India, Ireland, Japan, Malaysia, Macedonia, Mexico, Netherlands, New Zealand, Nepal, Peru, Poland, Russ…

Why it was recalled

The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Healthcare DigitalDiagnost System X-Ray