The Recall Desk
HighFDA (Devices)·Z-2857-2018·Announced 2018-08-29

Philips DigitalDiagnost Classic Footplate Hook Recall for Injury Risk

Philips is recalling DigitalDiagnost Classic 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, which aligns with the High severity criteria for medical devices.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling specific units of the DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052. The recall is due to a defect in the hook mechanism that fails to securely hold the footplate in the vertical position.

Because the hook does not hold the footplate securely, the footplate can fall or swing down. This malfunction creates a risk of injury to either the operator or the patient. The affected units were distributed in the United States and internationally to 66 countries.

The recall includes specific serial numbers listed in the agency's documentation. Users of these devices should contact the recalling firm for instructions on how to resolve the defect and ensure the safety of the equipment.

The recalled product

Product
DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052

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 →

Same manufacturer · Philips Medical Systems Gmbh, DMC

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