Recalls / —
—#114371
Product
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
- FDA product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K982795
- Affected lot / code info
- All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
Why it was recalled
With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.
Root cause (FDA determination)
Software design
Action the firm took
Philips Healthcare initiated a recall on October 25, 2012 via Urgent - Field Safety Notice for the Digital Diagnost X-ray System. The letter identified the affected product, problem and actions to be taken. The letter informs customers that Philips will supply a software update kit to version 2.1.4. For questions please contact your local Philips representative 1-800-722-9377.
Recalling firm
- Firm
- Philips Healthcare Inc.
- Address
- 3000 Minuteman Road, Andover, Massachusetts 01810
Distribution
- Distribution pattern
- Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, India, Indonesia, Iraq, Italy, Japan, Latvia, Lithuania, Libya, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.
Timeline
- Recall initiated
- 2012-10-30
- Posted by FDA
- 2012-12-05
- Terminated
- 2017-01-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #114371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.