Philips DigitalDiagnost Release 3 Footplate Hook Recall
Philips is recalling DigitalDiagnost Release 3 units because a defective hook may allow the footplate to fall or swing, posing a risk of injury to patients or operators.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect that can cause physical injury to patients or operators, meeting the criteria for a Severe rating.
Plain-English summary
Philips Medical Systems Gmbh, DMC is recalling DigitalDiagnost Release 3 (Stitching Patient Support) 712025 units. The recall involves specific serial numbers listed in the agency record, including 510694/SN12000240, 510890/SN12000259, and others. The affected units 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. As a result, the footplate can fall or swing down, which may injure the operator or the patient.
Healthcare facilities should identify any affected units by checking the serial numbers against the list provided by the manufacturer. Users should stop using the affected equipment and contact Philips Medical Systems for instructions on repair or replacement.
The recalled product
- Product
- DigitalDiagnost Release 3 (Stitching Patient Support) 712025
- 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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