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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Ultrasound QStation

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  Class 2 Device Recall Philips Ultrasound QStation see related information
Date Initiated by Firm May 15, 2015
Date Posted June 15, 2015
Recall Status1 Terminated 3 on August 08, 2016
Recall Number Z-1807-2015
Recall Event ID 71432
510(K)Number K140808  
Product Classification System, image processing, radiological - Product Code LLZ
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.
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 
Recalling Firm/
Manufacturer		 Philips Ultrasound, Inc.
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact
800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = PHILIPS ULTRASOUND, INC.
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