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.
This recall has been terminated (originally issued July 23, 2014).
- Company
- Philips Ultrasound, Inc.
- Recall Initiated
- July 9, 2014
- Posted
- July 23, 2014
- Terminated
- November 6, 2015
- Recall Number
- Z-2109-2014
- Quantity
- 25 units total (2 units in the US and 23 units outside the US)
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
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.
Lot / Code Info
*****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.
Root Cause
Software change control
Action Taken
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.