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ORION System with software OSS v6.0 and OSS v7.0- An… recallZ-0398-2024 · Leoni Cia Cable Systems · initiated Oct 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Leoni Cia Cable Systems or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-0398-2024
Status
Open, Classified
Initiated by the company
Oct 6, 2023
Posted by the FDA
Nov 21, 2023
Recalling firm
Leoni Cia Cable Systems
Quantity
1 unit
Product code
JAI
FDA submissions
K160518
Distribution
US Nationwide distribution in the states of MA, TN.

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

Code information (models, lots, serial numbers)

UDI-DI: (01)03700383510017 SN: 100000001141

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K160518 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93315).

Sources and updates

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