The Recall Desk
SevereFDA (Devices)·Z-2843-2018·Announced 2018-08-29

Philips DigitalDiagnost 4.1 Footplate Hook Recall for Injury Risk

Philips is recalling DigitalDiagnost 4.1 High Performance units because a defective hook allows the footplate to fall or swing, posing an injury risk to operators and patients.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect that can cause physical injury to patients or operators, meeting the criteria for a Severe rating.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling the DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031. The recall involves specific serial numbers: SN15000196, SN15000180, SN15000282, SN15000281, SN15000192, and SN15000189. The product was 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. Consequently, the footplate can fall or swing down, which may result in injury to the operator or the patient.

Healthcare facilities and users should stop using the affected units immediately. They should contact Philips Medical Systems for instructions on how to resolve the issue or obtain a replacement.

The recalled product

Product
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

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 →

Same manufacturer · Philips Medical Systems Gmbh, DMC

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