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.
Recall
- Recall Number
- Z-2109-2014
- Event Number
- 68756
- Firm
- Philips Ultrasound, Inc.
- FEI Number
- 3019216
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software change control
- Initiated
- July 9, 2014
- Posted
- July 23, 2014
- Terminated
- November 6, 2015
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431
Description
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.
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
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 at 1-866-767-7822.
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.
25 units total (2 units in the US and 23 units outside the US)