Philips Ultrasound — Class II medical device recall Z-1807-2015
Terminated recall by Philips Ultrasound, Inc., reported 2015-06-24, distributed nationwide. Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that cou
| Recall number | Z-1807-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound, Inc., Bothell, WA, United States |
| Recall initiated | 2015-05-15 |
| Classified | 2015-06-15 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-08-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CO, DE, ES, FR, GB, IN, IT, MX, NL, NO, PK, PL, RU, SG, TH |
| Serial numbers | 1ED3-QACA8669-1588, 2176-IAF08E60-15D4, 2187-VAC5T6CD-157D, 2B14-MDE9A2F9-1BC6, 2C98-25A23E3A-4B2E, 34F5-4084F543-80EA, 3A5D-4079F60B-80D4, 3C40-4972P842-92C1, 4489-SAD49B07-159C, 54B0-HADF24F2-15B1, 678B-NAE42F41-15BB, 6FF9-259B5EB7-4B20, 725B-GACE30D1-158F, 72EE-408914F8-80F2, 7A39-497627F7-92C9, 8536-IAD33B20-1599, A584-QAE84EF6-15C3, A838-IAE2CF5A-15B8, AAEC-MADD4FBE-15AD, B054-UAD25086-1597, B903-407CB5D9-80D9, BDC7-TAE25A0D-15B7, C897-TACC5B9D-158B, D356-YAE1E4C0-15B6, D60A-GADC6524-15AB and 14 more |
| Model numbers | 795088, 989605382391 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1807-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.