FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
- Recall number
- Z-0022-2015
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
- Status
- Terminated
- Initiated
- 2014-08-08
- Posted
- 2014-10-09
- Terminated
- 2014-12-03
- Reason
- Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips Healthcare discovered through field service testing, that the device was in violation. Firm service rep. visited site on 7/01/14 and corrected unit. The field service engineer immediately reprogrammed the generator for the X-ray tube installed in the system and re-adapted the x-ray tube to bring the system back into compliance. At this time the Failure to comply has been corrected and the customer has been notified. This correction is to be free of charge to the customer. For further questions please call (978) 687-1501.
- Quantity
- one system
- Distribution
- US distribution to FL
- Lot, serial or model codes
- Model Number: Integris Allura 15-12 Serial Number: 16741023
- 510(k) numbers
- ["K002016"]
- 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