Philips INTEGRIS Allura 9 Monitor Ceiling Suspension Recall
Philips is recalling INTEGRIS Allura 9 systems because the monitor ceiling suspension may detach, causing the monitor to fall and risk injury.
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 (falling monitor) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk of injury.
Plain-English summary
Philips Electronics North America Corporation is recalling INTEGRIS Allura 9 systems (System Code 722018) used for vascular, cardiovascular, neurovascular, and cardiac imaging applications. The recall involves 5,115 units distributed worldwide, including nationwide in the United States and in numerous international countries.
The recall is due to a potential defect 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, creating a risk of injury to the patient, user, and bystanders. All systems with an actuator for the FlexVision Monitor Ceiling Suspension manufactured between 2003 and May 2011 are affected.
Healthcare facilities should contact Philips for instructions on how to address this issue. The source text does not specify a particular action for consumers, but the risk applies to patients, users, and bystanders in the vicinity of the equipment.
The recalled product
- Product
- INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
- Manufacturer
- Philips Electronics North America Corporation
- Hazard
- 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
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