—#135515

Product

Philips Healthcare DigitalDiagnost System X-Ray

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141736
Affected lot / code info: Digital Diagnost Stationary X-ray System Release 4.0.0, 4.0.1, 4.0.2

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).

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

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

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated: 2015-02-09
Posted by FDA: 2015-05-19
Terminated: 2016-06-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135515. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.