The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2855-2018·Announced 2018-08-29

Philips DigitalDiagnost 4.1 High Performance Footplate Recall Issued

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 patients and operators.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 mechanical defect that can cause injury to patients or operators, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling the DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031. The recall was initiated because the hook on the device does not securely hold the footplate in the vertical position. This defect allows the footplate to fall or swing down, which can result in injury to the operator or the patient.

The affected units were distributed nationwide in the United States and internationally to 66 countries. The recall covers specific serial numbers, including SN15000291, SN16000158, and SN15000374, among others. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and users should check their inventory for the affected serial numbers. If a unit is identified, it should be removed from service to prevent potential injury to patients or staff. Users should contact the recalling firm for instructions on how to proceed with the recall.

The recalled product

Product
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
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 →

Related recalls

Same manufacturer · Philips Medical Systems Gmbh, DMC

See all →

Same hazard · falling object

See all →

Similar recalls