Forte Automation Patient Positioning System Recalled for Communication Failures
Forte Automation Systems is recalling 13 patient positioning systems in California due to periodic communication failures with the accuracy filter that may not be indicated to the operator.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for high-accuracy patient positioning where a failure could lead to procedural errors or injury, but no specific injuries or illnesses have been reported in the source text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Forte Automation Systems Inc is recalling 13 Patient Positioning Systems with KRC2 controllers. These systems are SCARA-designed robotic arms used to position patients for medical procedures requiring high accuracy and repeatability. The recall covers units distributed in California, specifically those using software versions 2.3.1 through 2.3.10.
The recall is being conducted because communications between the Patient Positioning System and the accuracy filter can periodically fail without providing a clear indication to the operator. This lack of feedback could compromise the system's ability to ensure accurate patient positioning during medical procedures.
Healthcare facilities and operators should stop using the affected units and contact Forte Automation Systems Inc for further instructions on remediation or replacement. The specific serial numbers and software versions affected are listed in the agency's recall documentation.
The recalled product
- Product
- 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 oncologists and others that require a high
- Manufacturer
- Forte Automation Systems Inc
- Affected units
- 13
Distribution
Distributed in 1 state:
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