FDA Medical Device Recalls (openFDA)
Philips North America: Integris-Allura IGTS Fixed Systems
- Recall number
- Z-0227-2024
- Recalling firm
- Philips North America
- Product
- Integris-Allura IGTS Fixed Systems
- Status
- Open, Classified
- Initiated
- 2023-10-04
- Posted
- 2024-09-30
- Terminated
- not on file
- Reason
- Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
- Root cause
- Device Design
- Action
- not on file
- Quantity
- not on file
- Distribution
- United States Territories of Puerto Rico, Guam, and Virgin Islands
- Lot, serial or model codes
- INTEGRIS Allura 15-12 (mono) 68
- 510(k) numbers
- ["K002016"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3006648320
- Firm city
- Cambridge
- 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