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Terminated

Azurion FlexArm, 722079

FDA Recall Z-1130-2019 · Posted None

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeJAA
Date Initiated2019-03-12
Date Terminated2020-10-07
Product Quantity2

Reason for Recall

During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.

Firm Action

On March 12, 2019, the firm distributed Urgent Medical Device Correction letters to affected consignees, alerting customers that the cable set in the C-arc of the Azurion R2.0 was not according to specifications, which resulted in damage of the 24V power cable of the detector. Customers were asked to place a copy of the field safety notice together with the documentation of the system until the system is inspected and corrected (if applicable) by Philips. The firm will inspect the affected systems free of charge and correct as necessary. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.

Root Cause

Component design/selection

Distribution Pattern

Distributed to one account in Florida, and one international account in Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181830Azurion R2.0Philips Medical Systems Nederland B.V. · 2018-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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