ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation
Summary
The FDA issued a Class II for ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic by LEONI CIA CABLE SYSTEMS. Reason: Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement .
Details
Source
Device Recall
External ID
Z-0398-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
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 Number: 1SOPT00003
Lot/Code Info: UDI-DI: (01)03700383510017 SN: 100000001141
Quantity Affected: 1 unit
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of MA, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-06
Company
Chartres, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LEONI CIA CABLE SYSTEMS has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LEONI CIA CABLE SYSTEMS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LEONI CIA CABLE SYSTEMS have FDA actions?
LEONI CIA CABLE SYSTEMS has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0398-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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