FDA Medical Device Recalls (openFDA)
Philips North America, LLC: Azurion FlexArm, 722079
- Recall number
- Z-1130-2019
- Recalling firm
- Philips North America, LLC
- Product
- Azurion FlexArm, 722079
- Status
- Terminated
- Initiated
- 2019-03-12
- Posted
- not on file
- Terminated
- 2020-10-07
- Reason
- 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
- 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
- 2
- Distribution
- Distributed to one account in Florida, and one international account in Germany.
- Lot, serial or model codes
- Serial numbers 637, 638
- 510(k) numbers
- ["K181830"]
- PMA numbers
- not on file
- Product code
- JAA
- 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