—#128605

Product

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K152165
Affected lot / code info: ****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.

Why it was recalled

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

Root cause (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Philips Ultrasound, Inc.
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

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.

Timeline

Recall initiated: 2014-07-09
Posted by FDA: 2014-07-23
Terminated: 2015-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128605. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.