The Recall Desk
HighFDA (Devices)·Z-2849-2018·Announced 2018-08-29

Philips DigitalDiagnost 4 Chest Footplate Recall Due to Injury Risk

Philips is recalling DigitalDiagnost 4 Chest units because a defective hook allows the footplate to fall or swing, posing a risk of injury to patients or 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 criteria for a High severity score.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling the DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029. The recall is due to a defect where the hook does not securely hold the footplate in the vertical position.

Because the footplate is not secured, it can fall or swing down, which may result in injury to the operator or patient. The affected units are identified by Serial Number SN16000395.

The recall covers distribution in the US Nationwide and internationally to 66 countries. Users should contact the recalling firm for instructions on how to resolve the defect.

The recalled product

Product
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number: SN16000395

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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