High FDA (Devices)·Z-2865-2018·Announced 2018-08-29

Philips DigitalDiagnost Dual-Detector Recall for Footplate Safety Hazard

Philips is recalling DigitalDiagnost Dual-Detector 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 is classified as FDA Class II and involves a risk of physical injury to patients and operators, but the source text does not report any actual injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling the DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052. The recall is due to a defect in the hook mechanism that is designed to hold the footplate in a vertical position. Because the hook does not securely hold the footplate, the footplate can fall or swing down unexpectedly.

This defect creates a risk of injury to both the patient and the operator. The recall covers units distributed in the United States and internationally to 66 countries. Specific serial numbers affected by this recall are listed in the agency's official documentation.

Healthcare facilities and users should stop using the affected units immediately. They should contact Philips Medical Systems for instructions on how to resolve the issue, which may involve repair or replacement of the defective component.

The recalled product

Product: DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052
Manufacturer: Philips Medical Systems Gmbh, DMC
Category: Medical Device — Imaging Equipment
Hazard: falling-object
physical-injury

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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Same hazard · falling object