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RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5… recallZ-1466-2020 · Raysearch Laboratories AB · initiated Feb 20, 2020

Terminated

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 Raysearch Laboratories AB 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

There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.

FDA root cause category: Under Investigation by firm

What the company is doing

An Urgent Field Safety Notice, Medical Device Correction notification letter dated 2/19/20 was emailed to the customer. ACTIONS TO BE TAKEN BY THE USER " Either do not use the RayTreat tabletop propagation functionality or make sure to always perform imaging and registration correction before each treatment session. " When using RayTreat in combination with the ProNova machine, do not use the acquired imaging positions in the preparation tab as the truth about where an image was actually taken. Please educate all users including the planning, Quality Assurance and plan delivery staff about this workaround. Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by replying to the notification email. SOLUTION This issue will be resolved in the next version of RayStation, scheduled for market release in March 2020 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. TRANSMISSION OF THIS NOTICE This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as any version of RayStation affected by this issue is in use to ensure effectiveness of the workaround.

Recall details

Recall number
Z-1466-2020
Status
Terminated
Initiated by the company
Feb 20, 2020
Recalling firm
Raysearch Laboratories AB
Quantity
1 system in the U.S.
Product code
MUJ
FDA submissions
K190387
Distribution
The products were distributed to the following US states: TN

Product description

RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system

Code information (models, lots, serial numbers)

UDI 07350002010235

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

2 devices cleared under K190387 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 85065).

Sources and updates

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