Philips DigitalDiagnost Single Detector Footplate Hook Recall
Philips is recalling DigitalDiagnost Single 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 involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for medical devices with potential for physical injury.
Plain-English summary
Philips Medical Systems Gmbh, DMC is recalling the DigitalDiagnost Single Detector (Stitching Patient Support) 712020. The recall involves specific serial numbers listed in the structured product information. The devices were distributed in the United States and internationally to 66 countries.
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 an operator or patient.
Healthcare facilities should identify affected units by checking the serial numbers against the provided list. Users should contact Philips Medical Systems for instructions on how to resolve the issue.
The recalled product
- Product
- DigitalDiagnost Single Detector (Stitching Patient Support) 712020
- 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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