CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report
Q-Station Quantification recalled by Philips Ultrasound
Philips Ultrasound is recalling Q-Station Quantification, distributed in 32 states. The recall was initiated on 5 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0818-2015
- FDA event ID
- 69790
- Recalling firm
- Philips Ultrasound, Bothell, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2014
- FDA classified
- 16 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Imaging Equipment
Timeline
| 5 Nov 2014 | Recall initiated by company | |
| 16 Dec 2014 | Classified by FDA | +41 days |
| 24 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
Where it was distributed
Worldwide distribution (for FCO 83000190): US, including the states of AK, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, and WI; and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Germany, Ecuador, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, Norway, New Zealand, Philippines, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, and Vietnam. ********************************************************************************** Worldwide Distribution -- US, including the states of KY, TN, ME, CA, PA, NC, CT, NY, SC, IL, IN, and WI; and the countries of Argentina, Spain, India, Italy, Austria, Germany, Belgium, Canada, Finland, Switzerland, Greece, Malaysia, Sweden, Australia, Netherlands, Mexico, Peru, Taiwan, Japan, France, and Norway.
AlaskaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyMassachusettsMarylandMaineMichiganMinnesotaMissouriNorth Carolina
Questions about this recall
Is Q-Station Quantification recalled?
Yes. Philips Ultrasound recalled Q-Station Quantification on 5 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0818-2015.
Why was it 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.
Which lots are affected?
SERIAL NUMBERS FOR FCO 79500321- Q-Station Quantification Software SYSTEM: 16B7-KADBT53D-15A9, 196B-UAD585A1-159E, 1ED3-QACA8669-1588, 2187-VAC5T6CD-157D, 2C46-QADA8FF0-15A8, 2EFA-RAD51054-159D, 3716-IAC49180-157C, 41D5-NADA1AA3-15A7, 4489-SAD49B07-159C, 49F1-IAC99BCF-1586, 4CA5-UAC41C33-157B, 5764-MAD9A556-15A6, 5A18-QAD425BA-159B, 5CCC-HACEA61E-1590, 5F80-MAC92682-1585, 6CF3-WAD93009-15A5, 725B-GACE30D1-158F, 750F-TAC8B135-1584, 8282-JAD8BABC-15A4, 8536-IAD33B20-1599, 87EA-PACDBB84-158E, 8A9E-RAC83BE8-1583, 9811-WAD8456F-15A3, 9D79-WACD4637-158D, AAEC-MADD4FBE-15AD, ADA0-PAD7D022-15A2, B054-UAD25086-1597, B308-JACCD0EA-158C, B5BC-RAC7514E-1581, C07B-KADCDA71-15AC, C897-TACC5B9D-158B, D60A-GADC6524-15AB, D8BE-KAD6E588-15A0, DB72-RAD165EC-1595, DE26-WACBE650-158A, E0DA-XAC666B4-157F, EE4D-IAD6703B-159F, F3B5-IACB7103-1589, F669-PAC5F167-157E, H944-VACAFBB6-1589, MBF8-WAC57C1A-157E, T3DC-SAD5FAEE-159F, and Y690-GAD07B52-1594.
Where was it sold?
Worldwide distribution (for FCO 83000190): US, including the states of AK, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, and WI; and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Germany, Ecuador, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, Norway, New Zealand, Philippines, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, and Vietnam. ********************************************************************************** Worldwide Distribution -- US, including the states of KY, TN, ME, CA, PA, NC, CT, NY, SC, IL, IN, and WI; and the countries of Argentina, Spain, India, Italy, Austria, Germany, Belgium, Canada, Finland, Switzerland, Greece, Malaysia, Sweden, Australia, Netherlands, Mexico, Peru, Taiwan, Japan, France, and Norway.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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