The Recall Desk
HighFDA (Devices)·Z-2851-2018·Announced 2018-08-29

Philips DigitalDiagnost 4 Footplate Hook Recall for Injury Risk

Philips is recalling DigitalDiagnost 4 High Performance 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 or operators, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling the DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027. The recall involves specific serial numbers distributed in the United States and internationally to 66 countries.

The recall is due to a defect in the hook that does not securely hold the footplate in the vertical position. As a result, the footplate can fall or swing down, which may injure an operator or patient.

Affected units are identified by the serial numbers listed in the agency's structured data. Users should contact the recalling firm for instructions on how to resolve the issue.

The recalled product

Product
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
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 →

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