FDA Medical Device Recalls (openFDA)
Philips Healthcare: Azurion systems with software release R2.0.x
- Recall number
- Z-0734-2022
- Recalling firm
- Philips Healthcare
- Product
- Azurion systems with software release R2.0.x
- Status
- Completed
- Initiated
- 2021-05-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated February 8, 2022. Philips Field Service Engineers will schedule an appointment with customers to install the software update. Philips will correct the affected systems at no cost to customers with a software upgrade. For information, contact your local Philips representative: 1-800-722-9377.
- Quantity
- 69 systems
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Model(s) Azurion R2.1
- 510(k) numbers
- ["K200917"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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