System, X-ray, Angiographic
Radiology · 21 CFR 892.1600
Recent MDR events
7,625 adverse event reports on file
- Allura Xper FDJul 31, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001968
- Allura Xper FDJul 31, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001976
- Allura Xper FDJul 31, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001980
- Allura Xper FDJul 31, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001986
- Allura Xper FDJul 30, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001954
- Allura Xper FDJul 30, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001958
- Allura Xper FDJul 29, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001942
- Allura Xper FDJul 29, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001923
- Allura Xper FDJul 29, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001944
- Allura Xper FDJul 29, 2026MalfunctionPhilips Medical Systems Nederland B.v.3042175844-2026-001947
Event type breakdown
Recalls
259 recall events for this product code
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Open, ClassifiedJun 16, 2026
Philips MultiDiagnost Eleva with the following Model Numbers:
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Z-2411-2026 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
INTEGRIS Allura 9, System Code 722018
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3213-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
INTEGRIS Allura 9 (biplane), System Code 722021
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3214-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
INTEGRIS CV, System Code 722030
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3215-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
INTEGRIS Allura 15-12 (mono), System Code 722043
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3216-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
INTEGRIS Allura 15-12 (biplane), System Code 722044
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3217-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
INTEGRIS SUITE, System Code 722199
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3218-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
INTEGRIS Allura 9 F FDXD, System Code 722497
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3219-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
NTEGRIS Allura 9 0 FDXD, System Code 722498
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3220-2018 · View FDA record ↗ - Philips Electronics North America CorporationTerminatedSep 21, 2018
Allura Xper FD2O, System Code 722006
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
Z-3221-2018 · View FDA record ↗
Registered firms
373 firms currently registered for this product code
Shimadzu Corporation Medical Systems Division
KYOTO, JP
Expeditors International Bv
Amsterdam Noord-Holland, NL
Bio Analitica Argentina S.a.
Ciudad Autonoma de Buenos Aires, AR
Block Imaging Parts & Service
Holt, MI, US
Carestream Health, Inc.
Rochester, NY, US
Arthrex California Technology, Incorporated
Santa Barbara, CA, US
Ge Medical Systems Scs
BUC, FR
Sterilization Services Of Georgia, Inc.
ATLANTA, GA, US
Pie Medical Imaging B.v.
MAASTRICHT Limburg, NL
Ortosistemas, S.a.
Panama, PA
Centurion Medical Products, Lp
Williamston, MI, US
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Arthrex Japan G.k. (shinjuku)
Shinjuku-ku Tokyo, JP
Expeditors
Mississauga Ontario, CA
Medical Resale Pty Limited
Caloundra QLD Queensland, AU
Prolinair Asia Limited
Ha Tsuen, Yuen Long, N.T., HK
Siemens Healthineers Ag
FORCHHEIM Bavaria, DE
Cyber Robotic Solutions, S.a De C.v.
Obarrio, Provincia de Panama, PA
Alem
Quito Pichincha, EC
510(k) clearances
199 clearances for this product code
- Stryker EndoscopyMay 28, 2026
K261037 · 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
- Surgimage CorporationMay 13, 2026
K253181 · SURGIMAGE SIM 1000H Fluorescence Imaging Platform
- Diagnostic Green GmbHSep 22, 2025
K243645 · IC-Flow Imaging System 2.0
- Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)Jun 27, 2025
K243077 · Affirm 800
- Synaptive Medical, Inc.Mar 25, 2024
K231986 · Modus IR
- Surgvision GmbHMar 20, 2024
K234090 · EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
- Carl Zeiss Meditec, Inc.Jun 20, 2023
K231075 · Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
- Novadaq Technologies Ulc (A Part of Stryker)Jun 5, 2023
K230727 · SPY Portable Handheld Imaging (SPY-PHI) System