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Radixact Treatment Delivery System recallZ-2489-2023 · Accuray Incorporated · initiated Aug 3, 2023

Completed

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 Accuray Incorporated 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

It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.

FDA root cause category: Device Design

What the company is doing

The recalling firm began issuing letters dated 7/19/2023 via hand-delivery by the field service engineer. The letter explained the issue and explained that if their Radixact System is being serviced by a third-party provider, please ensure they are also aware and take relevant precautions while servicing the system. The product impacted by the issue was detailed. The letter explained the issue arises only during the servicing of the Radixact System and customers can continue the clinical use of their system. The letter informs the consignee that Accuray will inspect the upper roller bracket of each impacted Radixact system to confirm there is adequate clearance for a jib crane. If there is sufficient clearance, then no action is necessary. If there is insufficient clearance, then the old bracket will be replaced with the new bracket following the released updated service procedures. An acknowledgment form was enclosed documenting the consignee confirms understanding the content of the field safety notice and has distributed the information to all applicable members of their staff.

Recall details

Recall number
Z-2489-2023
Status
Completed
Initiated by the company
Aug 3, 2023
Posted by the FDA
Aug 31, 2023
Recalling firm
Accuray Incorporated
Quantity
82
Product code
IYE
FDA submissions
K161146
Distribution
Worldwide - US Nationwide distribution in the states of CA, GA, IL, LA, NJ, OR, PA, SC, SD, TX, and WA. There was government distribution and no military distribution. The countries of Australia, Belgium, Canada, Colombia, France, India, Indonesia, Italy, Japan, Kazakhstan, Malaysia, Poland, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Product description

Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI-DI number 00811376030009. Serial numbers 4010505, 4010506, 4010507, 4010508, 4010509, 4010510, 4010511, 4010513, 4010515, 4010516, 4010517, 4010518, 4010519, 4010521, 4010522, 4010523, 4010524, 4010525, 4010526, 4010527, 4010528, 4010529, 4010530, 4010531, 4010532, 4010533, 4010536, 4010537, 4010538, 4010539, 4010541, 4010542, 4010543, 4010544, 4010545, 4010546, 4010548, 4010549, 4010550, 4010551, 4010552, 4010553, 4010554, 4010555, 4010556, 4010557, 4010558, 4010559, 4010560, 4010561, 4010562, 4010563, 4010564, 4010565, 4010566, 4010567, 4010568, 4010569, 4010570, 4010571, 4010573, 4010574, 4010577, 4010579, 4010582, 4010583, 4010584, 4010585, 4010586, 4010587, 4010588, 4010589, 4010590, 4010592, 4010593, 4010594, 4010596, 4010599, 4010607, 4010600, 4010601, and 4010609.

Devices named in this recall

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

Product lines

Sources and updates

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