QLAB 10 — Class II medical device recall Z-2110-2014
Terminated recall by Philips Ultrasound, Inc., reported 2014-07-30, distributed in CA, IA, KY, MD, NY, PA, UT, VA…. The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditi
| Recall number | Z-2110-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc., Bothell, WA, United States |
| Recall initiated | 2014-07-09 |
| Classified | 2014-07-23 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2015-11-06 |
| Distributed | CA, IA, KY, MD, NY, PA, UT, VA, WA, WI |
| Countries outside the US | AU, BE, CA, CH, ES, IN, IT, JP, KR, NL, NZ, SE |
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.
Reason for recall
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2110-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.