Recall Z-1807-2015 ยท LLZ System, Image Processing, Radiological
Philips Ultrasound, Inc.
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provide integrated tools that allow users to
| Date | Jun 15, 2015 (initiated May 15, 2015) |
| Status | Terminated |
| Reason | Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appended to subsequent studies for other patients. |
| Root cause | Software design |
| Action | PhilipsHealthcare sent an URGENT - Medical Device Correction Philips Ultrasound Q-Station, Q-STATION STRUCTURED REPORTING AND MEASUREMENTS letter, FCO 79500335, dated 2015 May 15, to all affected consignees. Philips is sending a CD with Q-Station software version 3.3.2 to consignees for a free of charge. Consignees must uninstall previous versions of Q-Station and install version 3.3.2 on your system carefully following the installation instructions that accompany the CD. It is important that consignees register their Q Station 3.3.2 installation as described in those instructions, so that |
| Quantity | 125 units (30 in US and 95 international) |
| Distribution | Worldwide Distribution - US (nationwide) and Puerto Rico; internationally to Australia, Canada, Colombia, France, Germany, Great Britain, India, Italy, Mexico, Netherlands, Norway, Pakistan, Poland, Russia, Singapore, Spain, Switzerland, Thailand, and Zimbabwe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140808 | Q-STATION Philips Ultrasound, Inc., Apr 17, 2014 |