Philips OmniDiagnost X-ray System Recalled for Tilt Actuator Failure Risk
Philips is recalling 477 OmniDiagnost Classic X-ray systems because a broken tilt actuator could cause the table to rotate uncontrollably, posing a risk of injury.
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 involves a mechanical defect that could cause a patient to fall from a rotating table, posing a significant risk of injury to patients, users, or bystanders, which aligns with the criteria for significant injury reports or high-risk mechanical failures.
Plain-English summary
Philips Medical Systems Nederlands is recalling 477 units of the OmniDiagnost Classic X-ray system (Product Nos. 70859, 708023, 708024, 708025). The recall covers systems distributed nationwide in the United States.
The recall is due to a defect where the fixation of the upper and lower tilt actuator might break off. If this occurs, the table may start to rotate from 0 to +90/-90 degrees at high speed. This rotating movement cannot be stopped by the user, which could potentially lead to a patient falling off the table. There is a risk of injury for the patient, user, or bystander.
Healthcare facilities should identify affected units by checking the As-Maintained System Equipment Number against the list provided in the official recall notice. Users should contact Philips Medical Systems Nederlands for instructions on how to resolve the issue.
The recalled product
- Product
- OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
- Manufacturer
- Philips Medical Systems Nederlands
- Category
- Medical Device — X-ray Systems
- Affected units
- 477
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems Nederlands 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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