FDA Device recall Z-2109-2014
QLAB 10 Core Module PN 453561704771
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of QLAB 10 Core Module PN 453561704771 by Philips Ultrasound, citing the QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2109-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-09 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Ultrasound |
| Distribution | CA, IA, KY, MD, NY, PA, UT, VA, WA, WI |
Product
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.
Reason
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Identifiers
| code_info | *****SYSTEM BASED ID OUTSIDE THE US********** 120F-P213FA35-V41E, 279E-Q21384E8-P41D, 3FBF-X2649F25-J4BF, 47FD-Q1F…*****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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2109-2014%22
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