510(k) K033737 ยท OWB Interventional Fluoroscopic X-Ray System
ALLURA XPER FD20
| Applicant | Philips Medical Systems North America, Inc., Da Best, NL |
| Decision | Substantially Equivalent, Dec 9, 2003 |
| Received | Nov 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033737
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10 -
Catalog numbers: (1) 722003, (2) 722010, (3) 722026, Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/10; Catalog numbers: 722029 Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/15; Catalog numbers: 722058 Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD20/20; Catalog numbers: 722038 Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura CV20; Catalog numbers: 722031 Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). Open, Classified |
OWB | None listed |
| Feb 20, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY); Open, Classified |
OWB | None listed |
| Feb 4, 2025 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AlluraXper FD20
System Code:
(1) 722006
(2) 722012
(3) 722028 Open, Classified |
OWB | None listed |
| Feb 16, 2024 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems.
Affected PCs: FlexVision PC
Allura Xper Model Name - Model Number:
Open, Classified |
OWB | None listed |
| Feb 19, 2019 | Philips Medical Systems Nederlands Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038
Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, Terminated |
IZI | None listed |
| Feb 19, 2019 | Philips Medical Systems Nederlands Foot Switches used with the following systems:
722001 Allura Xper FD 10 C
722002 Allura Xper FD10 F
722003 Allura Xper FD10
722005 Allura Xper FD10/10
722006 Allura Xper FD20
722008 Allura Xper FD2 Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper FD2O, System Code 722006
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper FD2O, System Code 722012
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper FD2O Biplane, System Code 722013
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper FD2O Biplane, System Code 722008
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | None listed |
| Mar 22, 2017 | Philips Electronics North America Corporation The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 Terminated |
OWB | None listed |
| Jan 20, 2017 | Philips Electronics North America Corporation Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pace Terminated |
OWB | None listed |
| Dec 9, 2016 | Philips Electronics North America Corporation Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura Terminated |
IZI | None listed |
| Dec 9, 2016 | Philips Electronics North America Corporation Velara Generator with an old Firmware version used with the Philips Integris BH5000 Terminated |
IZI | None listed |
| Feb 16, 2016 | Philips Electronics North America Corporation Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C Terminated |
IZI | None listed |
| Feb 5, 2016 | Philips Electronics North America Corporation Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications. Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Allura Xper Series:
Allura Xper FD10
Allura Xper FD10/10
Allura Xper FD20
Allura Xper FD21
Allura Xper FD22
Allura Xper FD23
Allura Xper FD24
Allura Xper FD25
Product Usage:
The A Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Allure BiPlane Series:
Model
722013 Allura Xper FD20 BIPLANE R7.6
722013 Allura Xper FD20 BIPLANE R7.7
722013 Allura Xper FD20 BIPLANE R7.8
722013 Allura Xper FD20 BIPLA Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare INTEGRIS cardio system
Model : 722121
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, i Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare INTEGRIS vascular System
Model : 722122
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare INTEGRIS H5000F/Allura 9F
Model : 722017
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper cardio systems
Model : 722123
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, inte Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper vascular system
Model : 722124
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, in Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper cardio systems R7.6
Model : 722133
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, Terminated |
OWB | None listed |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper vascular systems R7.6
Model : 722134
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics Terminated |
OWB | None listed |
| Nov 7, 2014 | Philips Medical Systems, Inc. Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028.
The Allura Xper FD series are intended for use on human patients to perform: Vascula Terminated |
OWB | None listed |
| Nov 7, 2014 | Philips Medical Systems, Inc. Philips Medical Systems Allura Xper FD20C with software version R8.2.O
System Code: 722035.
The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and n Terminated |
OWB | None listed |
| Sep 24, 2014 | Philips Medical Systems, Inc. Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper Terminated |
IZI | None listed |
| Apr 25, 2012 | Philips Healthcare Inc. Allura X-ray System.
The Allura X-ray System is an angiographic X-ray system. Terminated |
IZI | None listed |
| Aug 10, 2011 | Philips Healthcare Inc. Allura Xper Systems Models:
Allura Xper FD10 (F/C)-Biplane Fixed
Allura Xper FD10/10 (incl. OR table)
Allura Xper FD20- High resolution fixed-x ray
Allura Xper FD20/10
Allura Xper FD20/20
Allura CV20 Terminated |
IZI | None listed |
| Mar 22, 2011 | Philips Medical Systems North America Co. Phillips Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20.
Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER FD 20/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use for Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER FD20 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 PRODUCTS 6501 * (number located on the generator cabinet).
Intended use Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura 12-15 Monoplane.
The Monoplane system has one C-arm and it c Terminated |
IZI | None listed |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane.
The BIPLANE system has two C-arms and it allows the operator to im Terminated |
IZI | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Allura XPER FD20/10 Terminated |
IZI | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Allura XPER FD20 Terminated |
IZI | None listed |
| Dec 7, 2007 | Philips Medical Systems North America Co. Phillips Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021 Terminated |
IZI | None listed |
| Dec 7, 2007 | Philips Medical Systems North America Co. Phillips Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021 Terminated |
IZI | None listed |
| Nov 14, 2006 | Philips Medical Systems North America Co. Phillips Allura Xper FD 20/10 x-ray, and fluoroscopy Terminated |
IZI | None listed |
| Feb 28, 2006 | Philips Medical Systems North America Co. Phillips Allura Xper FD10 x-ray system Terminated |
IZI | None listed |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables used for connecting to the XPER systems. Terminated |
IZI | None listed |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems. Terminated |
IZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.