Injuries trigger recall related to tables used during image-guided procedures
Accident reports have prompted a recall related to Philips mattresses and tables used during image-guided procedures and surgeries.
The recall applies to Philips’ Allura and Azurion interventional fluoroscopy systems, which include dedicated tables and mattresses. Risks related to patients falling from the tables have been identified, prompting Philips to take action.
The recall does not involve removing the products from use, but rather an update of the devices’ instructions. However, the U.S. Food and Drug Administration has labeled the recall as the most serious type, as it could result in serious patient injury and even death if users do not follow Philips’ most up-to-date guidelines.
Philips’ latest instructions detail changes related to patient transfer, mattress selection and positioning.
For patient transfer, Philips issued the following guidance:
Communicate clearly with the other hospital staff during the transfer process to ensure that everyone is aware of the patient’s weight and position.
Open the air plug of the mattress. Opening the air plug allows the mattress to expand and contract with the weight of the patient.
Ensure that patient transfer devices are used correctly.
Move the patient carefully and avoid movements that could cause the mattress to slip.
If a patient positions themself on the table, ensure that the patient knows that the mattress is NOT fixed to the table.
For mattress selection and positioning, the updates are as follows:
Ensure the appropriate mattress is used on the tabletop.
Be aware that the mattress is placed on the tabletop with the table surface completely supporting the mattress.
Be aware of the narrow area of the neuro tabletop. Do not place the mattress where the tabletop is not underneath it.
In January, Philips issued an addendum to the instructions in an Urgent Medical Device Correction notice. Five injuries related to the systems’ use have been reported so far.
Questions and concerns can be directed to Philips representatives at 800-722-9377.
The complete list of affected devices can be found here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.