The Recall Desk
HighFDA (Devices)·Z-2858-2018·Announced 2018-08-29

Philips DigitalDiagnost Dual Detector Footplate Recall for Injury Risk

Philips is recalling DigitalDiagnost Dual Detector units because the footplate hook may fail, causing the plate 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 is classified as FDA Class II and involves a risk of physical injury to patients or operators, but the source text does not report any actual injuries or hospitalizations.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling the DigitalDiagnost Dual Detector (Stitching Patient Support) 712022. The recall involves specific serial numbers distributed in the United States and internationally to 66 countries.

The recall is due to a defect where the hook does not securely hold the footplate in the vertical position. As a result, the footplate can fall or swing down, which may injure the operator or the patient.

Affected units are identified by specific serial numbers listed in the recall documentation. Users should stop using the affected equipment and contact the manufacturer for instructions on repair or replacement.

The recalled product

Product
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
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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