Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azuri

FDA device recall Z-1647-2023 · posted 2024-09-30 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

Action taken

Philips issued Urgent Medical Device Letter to US consignees via e-mail on March 21, 2023 and certified email on March 29, 2023. Letters outside of the U.S.A. will be distributed through the local Philips Organizations. Letter states reason for recall, health risk and action to take: Keep this Medical Device Correction with the documentation of the system until Philips corrects your system. Circulate this notice to all users of the system so that they are aware of the issue. Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Medical Device Correction. US: Please return this signed form via email to: IGT_Recalls@philips.com or alternatively via regular mail to Philips at 222 Jacobs Street, Cambridge, MA 02141 for the attention of Mr. Roland Telson / 3rd Floor Philips is working on a software release that will correct this issue (reference FCO72200528). In the interim, until this software is available and installed in your affected system(s), Philips will be removing the Log Trace Files from the affected systems to free up disk capacity (reference FCO72200529). Philips will be prioritizing these activities based on the time the affected software release has been installed in the Philips Azurion system. You will be contacted by your local Philips representative to schedule these activities. If you need any further information or support concerning this issue, contact your local Philips representative.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OWB

Quantity affected

USA: 1063 R.O.W. 2136

Distribution

Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech R

Date initiated

2023-03-21

Date posted

2024-09-30

Location

Best, Netherlands

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