Home / Recalls / Philips Medical Systems, Inc. / Z-1554-2015

Z-1554-2015 Class II Terminated

Recalled by Philips Medical Systems, Inc. — Andover, MA

Recall Details

Product Type
Devices
Report Date
May 27, 2015
Initiation Date
February 9, 2015
Termination Date
June 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
54 DigitalDiagnost

Product Description

Philips Healthcare DigitalDiagnost System X-Ray

Reason for Recall

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).

Distribution Pattern

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, Russia, Saudi Arabia Singapore, Switzerland, Sweden, Spain, United Arab Emirates and United Kingdom.

Code Information

Digital Diagnost Stationary X-ray System Release 4.0.0, 4.0.1, 4.0.2

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