Patient Positioning System with KRC2 controller using software… — Class II medical device recall Z-2537-2018
Terminated recall by Forte Automation Systems Inc, reported 2018-08-01, distributed in CA. Communications between the Patient Positioning System and the accuracy filter can periodically fail with no cl
| Recall number | Z-2537-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Forte Automation Systems Inc, Machesney Park, IL, United States |
| Recall initiated | 2017-09-05 |
| Classified | 2018-07-24 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2020-04-13 |
| Distributed | CA |
| Quantity | 13 |
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 degree of accuracy and repeatability.
Reason for recall
Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2537-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.