The Recall Desk
HighFDA (Devices)·Z-3239-2018·Announced 2018-10-03

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.

What this means for you

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
Category
Medical Device — Imaging Equipment
Hazard
Affected units
5,115

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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 →

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