QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and

FDA device recall Z-2109-2014 · posted 2014-07-23 · Terminated

Recall details

Recalling firm

Philips Ultrasound, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LLZ

Quantity affected

25 units total (2 units in the US and 23 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 S

Date initiated

2014-07-09

Date posted

2014-07-23

Date terminated

2015-11-06

Location

Bothell, WA

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