The Recall Desk
HighFDA (Devices)·Z-2854-2018·Announced 2018-08-29

Philips DigitalDiagnost 4.1 Flex Footplate Recall for Injury Risk

Philips is recalling DigitalDiagnost 4.1 Flex and Value units because the footplate hook may fail, causing the footplate to fall and injure 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 4.1 Flex / Value (Stitching Patient Support) 712028. The recall is due to a defect where the hook does not securely hold the footplate in the vertical position.

Because the footplate can fall or swing down, there is a risk of injury to the operator or patient. The affected units were distributed in the US and internationally to 66 countries.

Healthcare providers should stop using the affected units and contact Philips for instructions on repair or replacement. Specific serial numbers for the affected units are listed in the official recall notice.

The recalled product

Product
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
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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