Philips Ultrasound, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2110-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.

Product Classification:

Class II

Date Initiated: July 9, 2014

Date Posted: July 30, 2014

Recall Number: Z-2110-2014

Event ID: 68756

Reason for Recall:

The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.

Status: Terminated

Product Quantity: 59 units total (12 units in the US and 47 units outside the US)

Code Information:

****SYSTEM BASED ID IN THE US*********************** 12DD-14B7BC8B-295F, 25EB-143A3021-2864, 3E1D-145FC2CB-28AF, 5914-14544E46-2898, 5936-13FD3F20-27EA, 91B6-1437E5A0-285F, 9C64-1478F656-28E1, A1DD-14426F8B-2874, AC8B-14838041-28F6, C501-13FAF49F-27E5, CCFB-144184F1-2872, and J57B-147C2B71-28E8. *****SYSTEM BASED ID OUTSIDE THE US************************ 189A-13D31774-2796, 1B4E-13CD97D8-278B, 2B31-1486400F-28FC, 2B42-145AB87C-28A5, 2E29-13D2A227-2795, 3099-147B40D7-28E6, 3B7A-1439BAD4-2863, 4BD4-13C1AE06-2773, 4E88-13BC2E6A-2768, 50E7-149054AD-2910, 512B-13E23661-27B4, 539B-148AD511-2905, 564F-14855575-28FA, 5682-1402BEBC-27F5, 5E5A-14A05E34-2930, 5E6B-1474D6A1-28D9, 611F-146F5705-28CE, 66CB-13B63981-275C, 6BCD-14B067BB-2950, 6ED6-13D14240-2792, 73E9-149FE8E7-292F, 76F2-13C0C36C-2771, 7951-1494E9AF-2919, 7C05-148F6A13-290E, 7C16-1463E280-28B7, 7C49-13E14BC7-27B2, 7C5A-13B5C434-275B, 7EA8-14B5720A-295A, 8465-13D0CCF3-2791, 8C5F-14175D45-281E, 8F35-13BACE83-2765, 91E9-13B54EE7-275A, A46F-1493FF15-2917, B74A-1499H964-2921, C4CE-147D8B58-28EA, D798-14AE1D3A-294B, D7A9-148295A7-28F4, DA5D-147D160B-28E9, DFB4-149D9E66-292A, DFC5-147216D3-28D3, E268-14981ECA-291F, E7BF-14B8A725-2960, EA95-145C1863-28A7, ED7C-13D4H20E-2797, F598-13C3833A-2776, FDA3-13DE8BF9-27AC, and XAF4-1445A4A6-287B.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated