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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
See all 28 products in this recall →Related recalls
Same manufacturer · Philips Medical Systems Gmbh, DMC
See all →- HighMedical Imaging Software Bug May Cause Incorrect X-ray Exposure
FDA (Devices) · 2021-09-08
- HighPhilips CombiDiagnost GCF X-ray System Software Recall
FDA (Devices) · 2020-02-26
- HighPhilips CombiDiagnost PCF X-ray System Software Recall
FDA (Devices) · 2020-02-26
- HighPhilips CombiDiagnost R90 X-ray System Recalled for Radiation Dose Risk
FDA (Devices) · 2019-02-20
- ModeratePhilips DigitalDiagnost Software Recall for X-ray System Stitching Defects
FDA (Devices) · 2018-10-31
Same hazard · falling object
See all →- SevereLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arms
CPSC · 2026-10-22
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
Similar recalls
- HighPhilips EasyDiagnost Patient Support Material Recalled for Footplate Safety Hazard
FDA (Devices) · 2015-12-09
- HighPhilips Digital Diagnost Patient Carriage Footplate Recall
FDA (Devices) · 2012-10-10
- HighPhilips BuckyDiagnost Patient Support Material Recall for Footplate Safety
FDA (Devices) · 2015-12-09
- HighPhilips Digital Diagnost Radiographic System Recall Due to Footboard Defect
FDA (Devices) · 2014-04-30
- HighPhilips Digital Diagnost Mobile Detector Holder Recall for Insecure Fit
FDA (Devices) · 2012-10-03
- ModeratePhilips DigitalDiagnost Software Recall for X-ray System Stitching Defects
FDA (Devices) · 2018-10-31