ClearanceBrief
510(k) K033737 ยท OWB Interventional Fluoroscopic X-Ray System

ALLURA XPER FD20

ApplicantPhilips Medical Systems North America, Inc., Da Best, NL
DecisionSubstantially Equivalent, Dec 9, 2003
ReceivedNov 28, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K033737

DateFirm and productCodeLinked 510(k)
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/10; Catalog numbers: 722029
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/15; Catalog numbers: 722058
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20; Catalog numbers: 722038
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura CV20; Catalog numbers: 722031
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
Open, Classified
OWBNone listed
Feb 20, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Open, Classified
OWBNone listed
Feb 4, 2025PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
Open, Classified
OWBNone listed
Feb 16, 2024PHILIPS 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
OWBNone listed
Feb 19, 2019Philips 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
IZINone listed
Feb 19, 2019Philips 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
IZINone listed
Sep 21, 2018Philips 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
IZINone listed
Sep 21, 2018Philips 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
IZINone listed
Sep 21, 2018Philips 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
IZINone listed
Sep 21, 2018Philips 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
IZINone listed
Mar 22, 2017Philips 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
OWBNone listed
Jan 20, 2017Philips 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
OWBNone listed
Dec 9, 2016Philips 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
IZINone listed
Dec 9, 2016Philips Electronics North America Corporation
Velara Generator with an old Firmware version used with the Philips Integris BH5000
Terminated
IZINone listed
Feb 16, 2016Philips 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
IZINone listed
Feb 5, 2016Philips Electronics North America Corporation
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Terminated
OWBNone listed
Feb 3, 2015Philips 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
OWBNone listed
Feb 3, 2015Philips 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
OWBNone listed
Feb 3, 2015Philips 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
OWBNone listed
Feb 3, 2015Philips 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
OWBNone listed
Feb 3, 2015Philips 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
OWBNone listed
Feb 3, 2015Philips 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
OWBNone listed
Feb 3, 2015Philips 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
OWBNone listed
Feb 3, 2015Philips 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
OWBNone listed
Feb 3, 2015Philips 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
OWBNone listed
Nov 7, 2014Philips 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
OWBNone listed
Nov 7, 2014Philips 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
OWBNone listed
Sep 24, 2014Philips 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
IZINone listed
Apr 25, 2012Philips Healthcare Inc.
Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.
Terminated
IZINone listed
Aug 10, 2011Philips 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
IZINone listed
Mar 22, 2011Philips 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
IZINone listed
Sep 22, 2010Philips 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
IZINone listed
Sep 22, 2010Philips 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
IZINone listed
Sep 22, 2010Philips 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
IZINone listed
Sep 22, 2010Philips 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
IZINone listed
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Allura XPER FD20/10
Terminated
IZINone listed
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Allura XPER FD20
Terminated
IZINone listed
Dec 7, 2007Philips Medical Systems North America Co. Phillips
Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021
Terminated
IZINone listed
Dec 7, 2007Philips Medical Systems North America Co. Phillips
Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
Terminated
IZINone listed
Nov 14, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD 20/10 x-ray, and fluoroscopy
Terminated
IZINone listed
Feb 28, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD10 x-ray system
Terminated
IZINone listed
Nov 29, 2005Philips 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
IZINone listed
Nov 29, 2005Philips 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
IZINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.