The Recall Desk
HighFDA (Devices)·Z-1807-2015·Announced 2015-06-24

Philips Q-Station Ultrasound Software Recalled for Data Integrity Issues

Philips is recalling Q-Station ultrasound software because patient measurements may be incorrectly appended to other patients' studies.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the 'High' severity criteria for potential data integrity issues affecting patient care.

Plain-English summary

Philips Ultrasound, Inc. is recalling the Q-Station application software, version 3.0 or higher. The software is used to manage, view, analyze, and report image data from ultrasound exams. The recall involves 125 units, with 30 located in the United States and 95 internationally.

The recall is due to a problem where measurements from a specific study (Structured Report) could be appended to subsequent studies for other patients. This data integrity issue could lead to incorrect patient records. The affected units were distributed worldwide, including the United States, Puerto Rico, and various international locations.

Healthcare facilities should contact Philips Ultrasound for further instructions on how to address the software defect. The source text does not specify a corrective action such as a software patch or replacement, nor does it report any specific patient injuries or illnesses resulting from the defect.

The recalled product

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 desig
Manufacturer
Philips Ultrasound, Inc.
Category
Medical Device — Ultrasound Software
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Philips Ultrasound, Inc.

See all →

Same hazard · data integrity

See all →