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 Recall Z-2110-2014 · Posted 2014-07-23
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Recalling FirmPhilips Ultrasound, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-07-09
Date Terminated2015-11-06
Product Quantity59 units total (12 units in the US and 47 units outside the US)
Reason for Recall
The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Firm Action
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.
Root Cause
Software change control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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