The Recall Desk
HighFDA (Devices)·Z-2868-2018·Announced 2018-08-29

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.

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, 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
Category
Medical Device — Imaging Equipment
Hazard

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.

See all 28 products in this recall →

Related recalls

Same manufacturer · Philips Medical Systems Gmbh, DMC

See all →

Same hazard · falling object

See all →