Philips Ultrasound, Inc.: 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.

Recall number

Z-1807-2015

Recalling firm

Philips Ultrasound, Inc.

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.

Status

Terminated

Initiated

2015-05-15

Posted

2015-06-15

Terminated

2016-08-08

Reason

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

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

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.

Lot, serial or model codes

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

510(k) numbers

["K140808"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

3019216

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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