The Recall Desk
HighFDA (Devices)·Z-2846-2018·Announced 2018-08-29

Philips BuckyDiagnost Ceiling System Recalled for Footplate Safety Hazard

Philips is recalling BuckyDiagnost Ceiling Systems because the footplate hook may fail to hold the plate securely, posing a risk of injury 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 criteria for a High severity score.

Plain-English summary

Philips Medical Systems Gmbh, DMC is recalling the BuckyDiagnost Ceiling System (Stitching Patient Support) 704031. The recall is due to a defect where the hook does not securely hold the footplate in the vertical position.

Because the hook may fail to secure the footplate, the plate can fall or swing down, which presents a risk of injury to either the operator or the patient. The affected units were distributed nationwide in the United States and internationally to 66 countries.

Healthcare facilities should stop using the affected BuckyDiagnost Ceiling Systems immediately and contact Philips Medical Systems for instructions on how to resolve the issue. The specific serial number identified in the recall notice is 477195/SN11000090.

The recalled product

Product
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
Manufacturer
Philips Medical Systems Gmbh, DMC
Category
Medical Device — Radiology Equipment
Hazard

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 (1)

  • Serial Number: 477195/SN11000090

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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