The Recall Desk
HighFDA (Devices)·Z-2866-2018·Announced 2018-08-29

Philips DigitalDiagnost Footplate Hook Recall for Injury Risk

Philips is recalling DigitalDiagnost Single-Detect units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and 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 DigitalDiagnost, Single-Detect (Stitching Patient Support) units, catalog number 712062. 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 held securely, it can fall or swing down, which may result in injury to the operator or the 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 recall notice. Users should stop using the affected equipment and contact Philips Medical Systems for instructions on repair or replacement.

The recalled product

Product
DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
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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