Reported Jul 30, 2014 · Terminated
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view…
Philips Ultrasound, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Ultrasound, Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- 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.
- Lot codes and dates
- *****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.
- Amount recalled
- 25 units total (2 units in the US and 23 units outside the US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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