Philips DigitalDiagnost 4 Flex Footplate Recall for Injury Risk
Philips is recalling DigitalDiagnost 4 Flex and Value units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and 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 is classified as FDA Class II and involves a risk of physical injury to patients or operators, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems Gmbh, DMC is recalling the DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028. The recall involves specific serial numbers distributed in the United States 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 the affected units by checking the serial numbers listed in the official recall notice. Users should stop using the affected equipment and contact the manufacturer for instructions on repair or replacement.
The recalled product
- Product
- DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
- Manufacturer
- Philips Medical Systems Gmbh, DMC
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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