Z-2109-2014Class II

QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed...

Name: Z-2109-2014 QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed...
Creator: Philips Ultrasound, Inc.
Published: 2014-07-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-07-09 / Terminated / root cause: software

FDA source

Philips Ultrasound, Inc. began a recall of QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on... on 2014-07-09. FDA classified it as Class II and gives the reason as "The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2109-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-09
Posted: 2014-07-23
Terminated: 2015-11-06
Recalling firm: Philips North America LLC
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Root cause tag: software
FDA root cause: Software change control
Action: 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.
Quantity in commerce: 25 units total (2 units in the US and 23 units outside the US)
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.
Product codes and lots: *****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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2109-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2109-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-23
Z-2110-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-23

Product code LLZ

K152165Class IIS9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. / cleared 2015-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)