The Recall Desk
SevereFDA (Devices)·Z-2860-2018·Announced 2018-08-29

Philips DigitalDiagnost Footplate Hook Recall for Injury Risk

Philips is recalling DigitalDiagnost Rel.4 Upgrades because a defective hook may allow the footplate to fall or swing, potentially injuring patients or operators.

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 structural 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 DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084. The recall involves specific serial numbers: SN15000153, SN17000147, SN15000211, and SN17000160. The products were distributed nationwide 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 patient.

Healthcare facilities should identify the affected units by checking the serial numbers and contact Philips Medical Systems for instructions on how to proceed with the recall.

The recalled product

Product
DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084
Manufacturer
Philips Medical Systems Gmbh, DMC
Category
Medical Device — Imaging 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 Numbers: SN15000153 SN17000147 SN15000211 SN17000160

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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