Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Summary
The FDA issued a Class II for Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the by Accuray Incorporated. 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 cr.
Details
Source
Device Recall
External ID
Z-2489-2023
Action Date
2023-09-06
Status
Completed
Category
device
Product Description
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Lot/Code Info: 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.
Quantity Affected: 82
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-03
Company
Madison, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Accuray Incorporated has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accuray Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accuray Incorporated have FDA actions?
Accuray Incorporated has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2489-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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