Philips INTEGRIS SUITE Ceiling Monitor Suspension Recall
Philips is recalling INTEGRIS SUITE systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.
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, but the source text does not report any actual injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Electronics North America Corporation is recalling 5,115 INTEGRIS SUITE systems (System Code 722199) used for vascular, cardiovascular, neurovascular, and cardiac imaging applications. The recall affects systems equipped with an actuator for the FlexVision Monitor Ceiling Suspension manufactured between 2003 and May 2011.
The recall is issued because 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, or bystander.
The affected units were distributed nationwide in the United States and in numerous countries worldwide. Users should contact Philips for further instructions regarding the recall and potential repair or replacement of the affected components.
The recalled product
- Product
- INTEGRIS SUITE, System Code 722199 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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