The Recall Desk
HighFDA (Devices)·Z-2845-2018·Announced 2018-08-29

Philips DigitalDiagnost Footplate Hook Recall for Injury Risk

Philips is recalling DigitalDiagnost Release 3.1 units because a defective hook allows the footplate to fall or swing, posing an injury risk to operators or patients.

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, which aligns with the High severity criteria.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 units. 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 held securely, it can fall or swing down, which may result in injury to the operator or patient. The affected units were distributed in the United States and internationally to 66 countries.

Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Users should stop using the affected footplates and contact Philips Medical Systems for instructions on repair or replacement.

The recalled product

Product
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
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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