Philips DigitalDiagnost Dual Detector Footplate Recall for Injury Risk
Philips is recalling DigitalDiagnost Dual Detector units because a defective hook allows the footplate to fall or swing, 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 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 Dual Detector (Stitching Patient Support) 712022. The recall is due to a defect in the hook that 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.
The affected units were distributed nationwide in the United States and internationally to 66 countries. The recall includes specific serial numbers listed in the official FDA notice. Users should check their equipment serial numbers against the provided list to determine if their unit is affected.
Consumers and healthcare facilities should stop using the affected equipment and contact Philips Medical Systems for instructions on repair or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
- 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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