The Recall Desk
HighFDA (Devices)·Z-2856-2018·Announced 2018-08-29

Philips DigitalDiagnost Classic 1.x Upgrades Recalled for Footplate Safety Hazard

Philips is recalling DigitalDiagnost Classic 1.x Upgrades 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 DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081. The recall involves specific serial numbers: 456897/SN10000166, 402837/SN0802410, 2010345, and 410774/SN0802694. The products were distributed in the US 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.

Healthcare facilities should identify affected units by checking the serial numbers listed above. Users should stop using the affected equipment and contact Philips Medical Systems for further instructions on repair or replacement.

The recalled product

Product
DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
Manufacturer
Philips Medical Systems Gmbh, DMC
Category
Medical Device — Patient Support
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 Numbers: 456897/SN10000166 402837/SN0802410 2010345 410774/SN0802694

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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