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Terminated

Philips Healthcare DuraDiagnost X- Ray

FDA Recall Z-1555-2015 · Posted 2015-05-19

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeKPR
Date Initiated2015-02-09
Date Terminated2016-06-14
Product Quantity3 DuraDiagnost

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).

Firm Action

Philips Healthcare Planned action: 1. Philips healthcare will contact customers and initiate a software update to correct the software deficiency causing the problem. 2. Philips engineers will install the software. 3. Philips engineers will perform testing to ensure the software update was effective. 4. Corrections are to be made free of charge 5. Corrective actions should be completed by August 15, 2015 For further questions call (978) 659-7892

Root Cause

Software design (manufacturing process)

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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