Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2110-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-07-09 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2110-2014
Date of alert: 2014-07-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Ultrasound, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 14838041

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2110-2014 — 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.

Related