Philips INTEGRIS Allura 9 F FDXD Monitor Suspension Recall
Philips is recalling INTEGRIS Allura 9 F FDXD systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the monitor may fall and cause injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Philips Electronics North America Corporation is recalling 5,115 INTEGRIS Allura 9 F FDXD systems, System Code 722497. These systems are used for vascular, cardiovascular, and neurovascular imaging, cardiac diagnostics, and non-vascular interventions. The recall affects all systems with an actuator for the FlexVision Monitor Ceiling Suspension manufactured between 2003 and May 2011.
The recall is due to a potential safety hazard where the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft. If this occurs, the monitor may fall to the ground, posing a risk of injury to patients, users, and bystanders.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. No specific lot numbers or additional dates are provided in the source text beyond the manufacturing period for the actuator.
The recalled product
- Product
- INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Imaging Systems
- Affected units
- 5,115
Distribution
Part of a larger recall action
This product is one of 27 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 27 products in this recall →Related recalls
Same manufacturer · Philips Electronics North America Corporation
See all →- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
- ModeratePhilips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
- HighPhilips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
- HighPhilips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
- HighPhilips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03
Same hazard · falling object
See all →- SevereLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arms
CPSC · 2026-10-22
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
Similar recalls
- HighPhilips Allura X-Ray System Ceiling Suspension Recall
FDA (Devices) · 2015-12-09
- SeverePhilips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk
FDA (Devices) · 2015-12-09
- SeverePhilips Xper Vascular System Monitor Ceiling Suspension Recall
FDA (Devices) · 2015-12-09
- HighPhilips Allura Xper Series Recall Due to Ceiling Suspension Fall Risk
FDA (Devices) · 2015-12-09
- SeverePhilips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
FDA (Devices) · 2015-12-09
- HighPhilips INTEGRIS Cardio System Ceiling Suspension Recall
FDA (Devices) · 2015-12-09