Recall
Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by…
Forte Automation Systems Inc · 5 Sept 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.”
- Recall began
- 5 Sept 2017
- Company
- Forte Automation Systems Inc
- Device type
- Product code (JAI)
- Concerns
- K122413
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.