Reported Nov 29, 2023 · Ongoing
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in…
Leoni Cia Cable Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LEONI CIA CABLE SYSTEMS · 5 avenue Victor Hugo · Chartres, N/A · N/A
Is this the product you have?
- ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment
- Part Number1SOPT00009
- Lot codes and dates
- UDI-DI(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695
- Amount recalled
- 3 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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