Z-0671-2018Class II

Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2...

Name: Z-0671-2018 Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2...
Creator: Med Tec Inc
Published: 2017-11-08
License: https://open.fda.gov/license/

Medtec LLC / initiated 2017-11-08 / Terminated / root cause: software

FDA source

Med Tec Inc began a recall of Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2... on 2017-11-08. FDA classified it as Class II and gives the reason as "When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0671-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-08
Posted: 2018-02-21
Terminated: 2020-08-21
Recalling firm: Medtec LLC
Product: Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch. The system is intended to support a treatment table and add pitch and roll to normal X, Y, Z and yaw motions to provide 6-degree axis movement. The product includes an interface between the treatment planning system and the treatment table to direct the table motion based on coordinates supplied. These products connect or support a treatment table by use of various mounting plates.
Product code: JAI Couch, Radiation Therapy, Powered
Reason for recall: When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.
Root cause tag: software
FDA root cause: Other
Action: Customers were notified via email on about November 8, 2017. Instructions include to contact Civco Medical Solutions to arrange an update to the device. Until the update is accomplished, customers were instructed to review and acknowledge the notification, verify the actual pedestal location matches the pedestal location being locked into Protura software, and disable the auto load/zero functionality described in the IFU. For further questions, please call (712) 737-8688.
Quantity in commerce: 5 installations
Distribution: US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.
Product codes and lots: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.1 (M881920, M880610), MT6XSM1.7.2 (Lot M924170), MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3 (Lot M093990), MT6XSM1.7.3-1, MT6XSM1.7.3-3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0671-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0671-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

Product code JAI

K132084Class IIProtura Couch SoftwareMed-Tec, Inc. D/B/A Civco Medical Solutions / cleared 2013-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)