Philips CombiDiagnost R90 Footplate Hook Recall for Injury Risk
Philips is recalling CombiDiagnost R90 units because a defective hook may allow the footplate to fall, posing an injury risk 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 'High' severity criteria for potential physical injury without confirmed incidents.
Plain-English summary
Philips Medical Systems Gmbh, DMC is recalling the CombiDiagnost R90 (Stitching Patient Support) 709030. The recall involves specific units identified by serial numbers SN17000130 and SN17000018. These devices were distributed nationwide in the United States and internationally to 66 countries.
The recall is due to a defect in the hook that secures the footplate. The hook does not securely hold the footplate in the vertical position, which allows the footplate to fall or swing down. This malfunction creates a risk of injury to the operator or patient.
Affected users should contact Philips Medical Systems for instructions on how to resolve the issue. The source text does not specify a particular action such as stopping use or returning the device, but users should follow the manufacturer's guidance.
The recalled product
- Product
- CombiDiagnost R90 (Stitching Patient Support) 709030
- 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 Numbers: SN17000130 SN17000018
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
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