Z-2489-2023Class II

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

Name: Z-2489-2023 Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery...
Creator: Accuray Incorporated
Published: 2023-08-03
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2023-08-03 / Completed / root cause: design

FDA source

Accuray Incorporated began a recall of Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System on 2023-08-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-2489-2023
Classification: Class II
Status: Completed
Initiated: 2023-08-03
Posted: 2023-08-31
Recalling firm: Accuray Incorporated
Product: Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 82
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2489-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2489-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-06	2023-08-31

Product code IYE

K161146Class IIRadixact Treatment Delivery SystemAccuray Incorporated / cleared 2016-06-24

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)