Z-1130-2019Class II

Azurion FlexArm, 722079

Name: Z-1130-2019 Azurion FlexArm, 722079
Creator: Philips North America, LLC
Published: 2019-03-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-03-12 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of Azurion FlexArm, 722079 on 2019-03-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1130-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-12
Posted: 2019-04-11
Terminated: 2020-10-07
Recalling firm: Philips North America LLC
Product: Azurion FlexArm, 722079
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
Root cause tag: design
FDA root cause: Component design/selection
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.
Quantity in commerce: 2
Distribution: Distributed to one account in Florida, and one international account in Germany.
Product codes and lots: Serial numbers 637, 638

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1130-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1130-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-11

Product code JAA

K181830Class IIAzurion R2.0Philips Medical Systems Nederland B.V. / cleared 2018-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)