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.
Enforcement
- Recall Number
- Z-1807-2015
- Event ID
- 71432
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Ultrasound, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 24, 2015
- Initiation Date
- May 15, 2015
- Classification Date
- June 15, 2015
- Termination Date
- August 8, 2016
- Address
- 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431, United States
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.
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.
*****************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
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.
125 units (30 in US and 95 international)