RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient duri
FDA device recall Z-1155-2013 · posted 2013-04-20 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- Reason for recall
- A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
- Action taken
- Accuray issued an Urgent Advisory Notification letter dated March 27, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Field Service Engineers will be replacing the affected product. Questions and concerns are to be directed to Accuray Customer Support at 1-877-668-8667
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAI
- Quantity affected
- 16 devices are subject to correction.
- Distribution
- Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan.
- Date initiated
- 2013-03-27
- Date posted
- 2013-04-20
- Date terminated
- 2013-08-20
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROBOCOUCH PATIENT SUPPORT SYSTEM (K042146) | Accuray Incorporated | 2004-09-17 |