Philips Ultrasound, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1807-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 15, 2015

Date Posted: June 24, 2015

Recall Number: Z-1807-2015

Event ID: 71432

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.

Status: Terminated

Product Quantity: 125 units (30 in US and 95 international)

Code Information:

*****************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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated