Philips EasyDiagnost Eleva DRF Footplate Hook Recall
Philips is recalling EasyDiagnost Eleva DRF units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.
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, fitting the 'High' severity criteria for potential physical injury without confirmed incidents.
Plain-English summary
Philips Medical Systems Gmbh, DMC is recalling the EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050. The recall affects units distributed in the United States and internationally to 66 countries.
The recall is due to a defect where the hook does not securely hold the footplate in the vertical position. As a result, the footplate can fall or swing down, which may injure the operator or the patient.
Healthcare facilities should stop using the affected devices and contact Philips Medical Systems for instructions on repair or replacement. Specific serial numbers are listed in the official recall documentation.
The recalled product
- Product
- EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
- Manufacturer
- Philips Medical Systems Gmbh, DMC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by Philips Medical Systems Gmbh, DMC 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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