FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
- Recall number
- Z-0925-2017
- Recalling firm
- Philips Electronics North America Corporation
- Product
- Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
- Status
- Terminated
- Initiated
- 2016-12-01
- Posted
- 2017-01-20
- Terminated
- 2017-08-10
- Reason
- Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
- Root cause
- Process control
- Action
- Customers were notified of the recall via letter sent on 12/1/16. The letter explains the issue and the action that Philips plans to take.
- Quantity
- 2
- Distribution
- US: WA OUS: China, Spain, Korea, Republic of, Germany
- Lot, serial or model codes
- 159, 183
- 510(k) numbers
- ["K133292"]
- PMA numbers
- not on file
- Product code
- OWB
- 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