FDA Devices recall · Reported June 24, 2015
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provide integrated tools that allow users to manually assess and score cardiac wall motion and export images and / or exams and reports. Q-Stat
Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be app…
Philips Ultrasound, Inc. recalled Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 7… - a moderate-severity action.
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 7… was recalled by Philips Ultrasound, Inc. in June 24, 2015. Reason: Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that co…. Check the official notice for the remedy. Verify recall #Z-1807-2015 with the FDA Devices before acting.
The recall
Philips Ultrasound, Inc. issued this moderate-severity FDA Devices recall-Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that co….
- Moderate
- severity level
- 125 units
- affected scope
- Class II
- classification
- June 24, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1807-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provide integrated tools that allow users to manually assess and score cardiac wall motion and export images and / or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT and X-Ray modalities for reference viewing. It support connectivity to ultrasound systems, PACS and other DICOM storage repositories.
Reason for recall
Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appended to subsequent studies for other patients.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1807-2015 |
| Date reported | June 24, 2015 |
| Date initiated | May 15, 2015 |
| Recalling firm | Philips Ultrasound, Inc. |
| Firm location | Bothell, WA |
| Affected scope | 125 units (30 in US and 95 international) |
| Distribution | Worldwide Distribution - US (nationwide) and Puerto Rico; internationally to Australia, Canada, Colombia, France, Germany, Great Britain, India, Italy, Mexico, Netherlands, Norway, Pakistan, Poland, Russia, Singapore, Spain, Switzerland, T… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1807-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026