—#137745

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K140808
Affected lot / code info: *****************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

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Ultrasound, Inc.
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

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.

Timeline

Recall initiated: 2015-05-15
Posted by FDA: 2015-06-15
Terminated: 2016-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.