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RayStation 6 Service Pack 1, UDI #s 07350002010037 recallZ-2352-2020 · Raysearch Laboratories AB · initiated May 18, 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

Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

FDA root cause category: Software design

What the company is doing

On May 18, 2020, RaySearch Laboratories emailed an Urgent Field Safety Notice, Medical Device Correction #60564 letter to their customers. The letter listed the following actions to be taken by the users: always use the MC dose engine for final dose calculation, in robustness analysis, and dose tracking if possible (the MC dose engine is available in versions RayStation 6.0 and later); if the pencil beam dose engine is used for final dose calculation, ensure that all spots intersect the External ROI as seen in the Beams Eye View (BEV) of the Plan optimization module; if they do not, expand the External ROI so that all spots do intersect the External ROI, and re-optimize the plan if necessary; if the MC dose engine is used for final dose calculation, and hot spots related to tangential fields are observed, expand the External ROI so that the central axis of all spots intersect the External ROI and re-optimize the plan; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the above software version number(s). RaySearch Laboratories asked all customers to confirm that they have read and understood the notice by replying to the notification email.

Recall details

Recall number
Z-2352-2020
Status
Terminated
Initiated by the company
May 18, 2020
Recalling firm
Raysearch Laboratories AB
Product code
MUJ
FDA submissions
K190387
Distribution
US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.

Product description

RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

Code information (models, lots, serial numbers)

UDI #s 07350002010037, 07350002010082  Build number: 6.1.1.2

Devices named in this recall

2 devices 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 85723).

Sources and updates

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