Recall Z-2109-2014 ยท LLZ System, Image Processing, Radiological
Philips Ultrasound, Inc.
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
| Date | Jul 23, 2014 (initiated Jul 9, 2014) |
| Status | Terminated |
| Reason | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. |
| Root cause | Software change control |
| Action | Philips Medical Systems notified customers of the voluntary recall by sending a certified URGENT-Medical Device Correction letter, dated 2014 JUL 09, to all US and Canadian consignees. Philips representatives will distribute the letter internationally. Follow-up letters to wholesale customers will be provided and wholesalers are requested to forward copies of recall letters and response forms to their customers. Philips Medical Systems will also have Customer Reply Cards returned for tracking purposes. Customers are directed to call local Philips representative or Philips Customer Service |
| Quantity | 25 units total (2 units in the US and 23 units outside the US) |
| Distribution | Distributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA and WI. Also distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152165 | S9 Portable Digital Color Doppler Ultrasound System Sonoscape Medical Corp., Aug 26, 2015 |