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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Philips Ultrasound, Inc.
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
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