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.
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 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
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.
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