Philips OmniDiagnost X-ray System Recalled for Missing Locking Plate
Philips North America is recalling 1,696 OmniDiagnost Classic X-ray systems because a missing locking plate may cause unexpected stand or table movement that users cannot stop.
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 mechanical defect that poses a risk of harm (unexpected movement) to patients or staff, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Philips North America, LLC is recalling 1,696 units of the OmniDiagnost Classic X-ray system (Product Codes 70859, 708023, 708024, 708025). The recall is due to a potential defect where the locking plate may be missing from the system. This defect may result in unexpected stand or table tilt movement that cannot be stopped by the user.
The affected units were distributed domestically across the United States and internationally worldwide. The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users of the OmniDiagnost Classic X-ray system should contact Philips North America for instructions on how to resolve the issue. Users should verify the serial numbers of their equipment against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include…
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — X-ray System
- Affected units
- 1,696
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Philips North America, LLC 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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