The Recall Desk
HighFDA (Devices)·Z-2842-2018·Announced 2018-08-29

Philips DigitalDiagnost 4 Flex Footplate Recall Due to Injury Risk

Philips is recalling two DigitalDiagnost 4 Flex units because a defective hook allows the footplate to fall, posing an injury risk 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, fitting the High severity criteria for potential physical injury without confirmed incidents.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling two units of the DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028. The recall involves specific serial numbers SN17000395 and SN17000372. These devices were distributed nationwide in the United States and internationally to 66 countries.

The recall is being issued because the hook on the device 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.

Healthcare facilities and users should stop using the affected units immediately. Affected parties should contact the recalling firm for instructions on how to resolve the issue.

The recalled product

Product
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
Manufacturer
Philips Medical Systems Gmbh, DMC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Serial Numbers: SN17000395
  • SN17000372

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

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