FDA Device recall Z-2537-2018
Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCA…
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCA… by Forte Automation Systems, citing communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2537-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-05 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Forte Automation Systems |
| Distribution | CA |
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
Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
Identifiers
| code_info | PPS Serial Number Cabinet Type Software Version 7757-11 KRC2…PPS Serial Number Cabinet Type Software Version 7757-11 KRC2 2.3.3 7757-21 KRC2 2.3.3 7757-31 KRC2 2.3.3 7757-41 KRC2 2.3.3 7757-51 KRC2 2.3.8 7755-21 KRC2 2.3.3 7755-31 KRC2 2.3.3 7755-41 KRC2 2.3.3 7392-2 KRC2 2.3.3 7392-3 KRC2 2.3.3 7392-4 KRC2 2.3.3 7392-1 KRC2 2.3.8 7392-5 KRC2 2. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2537-2018%22
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