The Recall Desk
HighFDA (Devices)·Z-2862-2018·Announced 2018-08-29

Philips DigitalDiagnost Footplate Hook Recall Due to Injury Risk

Philips is recalling DigitalDiagnost Release 3.1 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, which corresponds to a High severity score under the rubric.

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 in the hook mechanism that fails to 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 were distributed nationwide in the United States and internationally to 66 countries.

Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Users should stop using the affected equipment and contact the manufacturer 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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