Philips Medical Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1554-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Philips Healthcare DigitalDiagnost System X-Ray

Product Classification:

Class II

Date Initiated: February 9, 2015

Date Posted: May 27, 2015

Recall Number: Z-1554-2015

Event ID: 70916

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).

Status: Terminated

Product Quantity: 54 DigitalDiagnost

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated