Z-0399-2024Class II

ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning...

Name: Z-0399-2024 ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning...
Creator: Leoni Cia Cable Systems
Published: 2023-10-06
License: https://open.fda.gov/license/

BizLink Robotic Solutions France / initiated 2023-10-06 / Open, Classified / root cause: software

FDA source

LEONI CIA CABLE SYSTEMS began a recall of 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... on 2023-10-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0399-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-06
Posted: 2023-11-21
Recalling firm: BizLink Robotic Solutions France
Product: 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: 1SOPT00009
Product code: JAI Couch, Radiation Therapy, Powered
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.
Root cause tag: software
FDA root cause: Software design
Action: BizLink s notified customer via email with delivery and read confirmation and with the Field Safety Notice (FSCA Ref: UMCU-638) on October 6, 2023. Letter states reason for recall, health risk and action to take: BizLink technical support team will contact customers shortly to organize the deployment of the hot fix in the proton-therapy treatment centers. While waiting for the hot fix, BizLink recommend that customers implement the following action at the customer software level to avoid this problem: Send a stopFast command just after reactivating the motionEnable / the E-stop / the collision detection by Safety Laser and before sending any other motion command. A hot fix to correct this bug has been developed. BizLink shall provide this hot fix (version OSS 6.1 and version OSS 7.3) and the detailed documentation so that customers can deploy the new software version on clinical sites available on October 27, 2023 at the latest. If you require further clarification, please feel free to contact our BizLink Team ([email protected]). Please return the signed copy of the FSN to BizLink ([email protected]) within 10 working days
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the states of MA, TN.
Product codes and lots: UDI-DI:(01)03700383510079 SN 100000004639 SN 100000004698 SN 100000004695

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0399-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0398-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21
Z-0399-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-21

Product code JAI

K160518Class IILEONI ORION SystemLeoni Cia Cable System / cleared 2016-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)