Philips Medical Monitor Ceiling Suspension Recall Due to Detachment Risk
Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach and fall, posing an injury risk to patients and 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-harm product where injury has not yet been reported, which corresponds to a score of 3 (High) per the rubric.
Plain-English summary
Philips Electronics North America Corporation is recalling 5,115 units of the Cesar Powerpack-Visub(V3000) Monitor Ceiling Suspension. The affected systems are used for vascular, cardiovascular, neurovascular, and cardiac imaging applications, as well as non-vascular interventions. The recall covers systems manufactured between 2003 and May 2011 that include an actuator for the FlexVision Monitor Ceiling Suspension.
The recall is being issued because the monitor ceiling suspension may detach from the actuator rotor shaft. If this occurs, the large screen monitor held by the suspension may fall. The source text notes that a falling monitor presents a risk of injury to the patient, the user, and any bystanders present.
The affected products were distributed nationwide in the United States and in numerous countries worldwide. Consumers and healthcare facilities should identify if they possess the affected equipment and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Cesar Powerpack-Visub(V3000), System Code 72243 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.
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