FDA Medical Device Recalls (openFDA)
Accuray Incorporated: Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
- Recall number
- Z-2489-2023
- Recalling firm
- Accuray Incorporated
- Product
- Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
- Status
- Completed
- Initiated
- 2023-08-03
- Posted
- 2023-08-31
- Terminated
- not on file
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K161146"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3003873069
- Firm city
- Madison
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28