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.
Enforcement
- Recall Number
- Z-2109-2014
- Event ID
- 68756
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Ultrasound, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 30, 2014
- Initiation Date
- July 9, 2014
- Classification Date
- July 23, 2014
- Termination Date
- November 6, 2015
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431, United States
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.
*****SYSTEM BASED ID OUTSIDE THE US********** 120F-P213FA35-V41E, 279E-Q21384E8-P41D, 3FBF-X2649F25-J4BF, 47FD-Q1FD112B-J3F0, 4A8F-U24EA0B5-R493, 5570-Q20D1AB2-W410, 5D8C-G1FC9BDE-N3EF, 684B-V2122501-R41A, 6DA2-G232AD5C-S45B, 731B-Q1FC2691-V3EE, 808E-P20C3018-I40E, 88AA-T1FBB144-W3ED, A0CB-I24CCB81-M48F, A0ED-H1F5BC5B-P3E1, AB9B-S236CD11-W463, BE98-V1E4C83A-P3BF, C6A3-H1FFD0F9-X3F5, CBE9-M24BE0E7-Y48D, EEFC-Y22FED8E-S455, EF0D-I20465FB-I3FE, F475-U1F966C3-X3E8, and V49C-R203F0AE-I3FE. ***********Two units shipped in US and one unit shipped outside the US to distributors do not have serial numbers. There are licensing agreements with these distributors that allows the distributors to create their own licensing and serial numbers and/or tracking information.
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)