Z-1807-2015Class II

Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number...

Name: Z-1807-2015 Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number...
Creator: Philips Ultrasound, Inc.
Published: 2015-05-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-05-15 / Terminated / root cause: software

FDA source

Philips Ultrasound, Inc. began a recall of Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software... on 2015-05-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1807-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-15
Posted: 2015-06-15
Terminated: 2016-08-08
Recalling firm: Philips North America LLC
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: PhilipsHealthcare sent an URGENT - Medical Device Correction Philips Ultrasound Q-Station, Q-STATION STRUCTURED REPORTING AND MEASUREMENTS letter, FCO 79500335, dated 2015 May 15, to all affected consignees. Philips is sending a CD with Q-Station software version 3.3.2 to consignees for a free of charge. Consignees must uninstall previous versions of Q-Station and install version 3.3.2 on your system carefully following the installation instructions that accompany the CD. It is important that consignees register their Q Station 3.3.2 installation as described in those instructions, so that Philips can confirm that they have completed this correction. Consignees were instructed to complete the enclosed Customer Reply Form to confirm that they have (1) read and understood this important Medical Device Correction and (2) have either installed Q-Station version 3.3.2 or declare that this FCO 79500335 does not apply to their institution. Consignees were asked to return the enclosed Customer Reply form to Philips Healthcare within 5 days of receipt of the replacement software. Consignees with questions can call local Philips representative or Philips Customer Service at 1-800-722-9377.
Quantity in commerce: 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, Thailand, and Zimbabwe.
Product codes and lots: *****************US Serial numbers***************************************** 2176-IAF08E60-15D4, 2187-VAC5T6CD-157D, 2C98-25A23E3A-4B2E, 34F5-4084F543-80EA, 3A5D-4079F60B-80D4, 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, B903-407CB5D9-80D9, BDC7-TAE25A0D-15B7, D356-YAE1E4C0-15B6, D60A-GADC6524-15AB, D8BE-KAD6E588-15A0, DB72-RAD165EC-1595, DE26-WACBE650-158A, E0DA-XAC666B4-157F, E16D-40814ADB-80E2, E8E5-TAE16F73-15B5, EE4D-IAD6703B-159F, F669-PAC5F167-157E, F90C-MAEBF95E-15CA, H944-VACAFBB6-1589, MBF8-WAC57C1A-157E, U9D7-4085DFDD-80EC. ********************Serial numbers in CANADA**************************************** 1ED3-QACA8669-1588, 4489-SAD49B07-159C, B054-UAD25086-1597, C897-TACC5B9D-158B, and F3B5-IACB7103-1589. *********************Serial numbers in other countries*********************************** 114F-QAE6M475-15BF, 11F3-40756109-80CB, 16B7-KADBT53D-15A9, 196B-UAD585A1-159E, 1F66-40856A90-80EB, 221A-407FEAF4-80E0, 23FD-4977FD2B-92CD, 242A-MAEBPEC4-15C9, 24CE-407A6B58-80D5, 2782-4074EBBC-80CA, 2965-496CFDF3-92B7, 29E4-25A7BDD6-4B39, 2C46-QADA8FF0-15A8, 2EFA-RAD51054-159D, 2F4C-259CBE9E-4B23, 3716-IAC49180-157C, 37A9-407F75A7-80DF, 3C6D-XAE519DB-15BD, 3CBF-25ACC825-4B43, 3D11-4074766F-80C9, 41D5-NADA1AA3-15A7, 47D0-4089FF92-80F4, 49F1-IAC99BCF-1586, 4C94-YAEFA3C6-15D2, 4CA5-UAC41C33-157B, 4F1B-49771291-92CB, 4FEC-407980BE-80D3, 524E-25AC52D8-4B42, 5764-MAD9A556-15A6, 5A18-QAD425BA-159B, 5CCC-HACEA61E-1590, 5F80-MAC92682-1585, 6013-4084IAA9-80E8, 61F6-497C1CE0-92D5, 62C7-407E8B0D-80DD, 657B-4079TB71-80D2, 6CF3-WAD93009-15A5, 750F-TAC8B135-1584, 75A2-4083955C-80E7, 7856-407E15C0-80DC, 7B0A-40789624-80D1, 7CED-4970A85B-92BE, 7D6C-25AB683E-4B40, 7FCE-HADE3A58-15AF, 8282-JAD8BABC-15A4, 87EA-PACDBB84-158E, 8A9E-RAC83BE8-1583, 8B31-4083200F-80E6, 8D14-497B3246-92D3, 8D41-NAEE43DF-15CF, 8DE5-407DA073-80DB, 8FF5-NAE8C443-15C4, 9099-407820D7-80D0, 9811-WAD8456F-15A3, 9D79-WACD4637-158D, A0C0-4082AAC2-80E5, A374-407D2B26-80DA, A628-4077AB8A-80CF, A80B-496FBDC1-92BC, AAEC-MADD4FBE-15AD, ADA0-PAD7D022-15A2, B308-JACCD0EA-158C, B39B-4087B511-80EF, B5BC-RAC7514E-1581, B64F-40823575-80E4, B832-497A47AC-92D1, B85F-UAED5945-15CD, BAE6-4974C810-92C6, BBB7-4077363D-80CE, BE19-25AAH857-4B3D, C07B-KADCDA71-15AC, CBDE-4081C028-80E3, CDC1-4979D25F-92D0, CE92-407C408C-80D8, D146-4076C0F0-80CD, E37D-JAEC6EAB-15CB, E421-407BCB3F-80D7, F448-4086552A-80EC, F6FC-4080D58E-80E1, F8DF-4978E7C5-92CE, F9B0-407B55F2-80D6, FC64-4075D656-80CB, T3DC-SAD5FAEE-159F, TF3F-407AE0A5-80D6, VC8B-40806041-80E1, and Y690-GAD07B52-1594. **********NEWLY ADDED FOUR AFFECTED SERIAL NUMBERS******* aaec-madd4fbe-15ad; WE9B-QAEB8411-15CA; 2B14-MDE9A2F9-1BC6; and 3C40-4972P842-92C1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1807-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1807-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-15

Product code LLZ

K140808Class IIQ-StationPhilips Ultrasound, Inc. / cleared 2014-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)