Recall Z-0886-2022— PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Name: FDA recall Z-0886-2022
Creator: U.S. Food and Drug Administration
Published: 2021-05-26

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., initiated 2021-05-26. It names one FDA 510(k) clearance: K172822. Product: Azurion systems with software release R1.x. 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..

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Classification: Class II
Status: Ongoing
Initiated: 2021-05-26
Firm location: Best, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K172822 — Azurion series R1.2Philips Medical Systems Nederland B.V.·cleared 2017-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Azurion systems with software release R1.x

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.