Philips NTEGRIS Allura 9 0 FDXD Ceiling Monitor Recall
Philips is recalling NTEGRIS Allura 9 0 FDXD systems because the ceiling monitor 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 physical injury from a falling object, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Electronics North America Corporation is recalling 5,115 NTEGRIS Allura 9 0 FDXD systems, System Code 722498. These systems are used for vascular, cardiovascular, neurovascular, and cardiac imaging applications, as well as non-vascular interventions.
The recall is due to a potential defect in the Monitor Ceiling Suspension. The suspension, which holds a large screen monitor, may detach from the actuator rotor shaft. If this occurs, the monitor may fall, posing a risk of injury to patients, users, and bystanders.
The affected units are all systems with an actuator for the FlexVision Monitor Ceiling Suspension manufactured between 2003 and May 2011. These systems were distributed worldwide, including nationwide in the United States and in numerous international countries. Users should contact Philips for instructions on how to address this issue.
The recalled product
- Product
- NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
- Manufacturer
- Philips Electronics North America Corporation
- 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.
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