QLAB 10.1 Core Module PN 453561728001. QLAB recall
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data…
Why was QLAB 10.1 Core Module PN 453561728001. QLAB recalled?
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
****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.
- Product
- QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data…
- Recalling firm
- Philips Ultrasound, Inc.
- Quantity
- 59 units total (12 units in the US and 47 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.
- Recall date
- July 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)