The Recall Desk
HighFDA (Devices)·Z-2853-2018·Announced 2018-08-29

Philips DigitalDiagnost 4.1 Chest X-Ray Unit Recalled for Footplate Hazard

Philips is recalling DigitalDiagnost 4.1 Chest X-Ray units because a defective hook allows the footplate to fall, 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 physical injury to patients or operators from a falling footplate, but the source text does not report any actual injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling the DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029. The recall is due to a defect in the hook that secures the footplate in the vertical position. Because the hook does not hold the footplate securely, the footplate can fall or swing down, which may result in injury to the operator or patient.

The affected units are identified by Serial Number SN15000433. The product was distributed nationwide in the United States and internationally to 66 countries. No specific dates or quantities are provided in the source text.

Consumers and healthcare facilities should stop using the affected equipment and contact the recalling firm for instructions on repair or replacement. The source text does not specify a particular action for consumers beyond the general recall notification.

The recalled product

Product
DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
Manufacturer
Philips Medical Systems Gmbh, DMC
Category
Medical Device — X-Ray Equipment
Hazard

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: SN15000433

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

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Same hazard · falling object

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