Reported Dec 24, 2014 · Terminated
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog…
Philips Ultrasound, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Ultrasound, Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected
- ModelQ-Station
- Catalog number795088
- and Part Number989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams
- Lot codes and dates
- SERIAL NUMBERS FOR FCO 79500321- Q-Station
- Quantification Software SYSTEM
16B7-KADBT53D-15A9196B-UAD585A1-159E1ED3-QACA8669-15882187-VAC5T6CD-157D2C46-QADA8FF0-15A82EFA-RAD51054-159D3716-IAC49180-157C41D5-NADA1AA3-15A74489-SAD49B07-159C49F1-IAC99BCF-15864CA5-UAC41C33-157B5764-MAD9A556-15A65A18-QAD425BA-159B5CCC-HACEA61E-15905F80-MAC92682-15856CF3-WAD93009-15A5725B-GACE30D1-158F750F-TAC8B135-15848282-JAD8BABC-15A48536-IAD33B20-159987EA-PACDBB84-158E8A9E-RAC83BE8-15839811-WAD8456F-15A39D79-WACD4637-158DAAEC-MADD4FBE-15ADADA0-PAD7D022-15A2B054-UAD25086-1597B308-JACCD0EA-158CB5BC-RAC7514E-1581C07B-KADCDA71-15ACC897-TACC5B9D-158BD60A-GADC6524-15ABD8BE-KAD6E588-15A0DB72-RAD165EC-1595DE26-WACBE650-158AE0DA-XAC666B4-157FEE4D-IAD6703B-159FF3B5-IACB7103-1589F669-PAC5F167-157EH944-VACAFBB6-1589MBF8-WAC57C1A-157ET3DC-SAD5FAEE-159Fand Y690-GAD07B52-1594
- Amount recalled
- 43 units (13 in US and 30 outside US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy.
This product could cause temporary or reversible health problems — stop using it.
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