Z-1992-2016Class II

Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number...

Name: Z-1992-2016 Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number...
Creator: Med Tec Inc
Published: 2016-03-31
License: https://open.fda.gov/license/

Medtec LLC / initiated 2016-03-31 / Terminated / root cause: software

FDA source

Med Tec Inc began a recall of Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO... on 2016-03-31. FDA classified it as Class II and gives the reason as "When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters". 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-1992-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-31
Posted: 2016-06-15
Terminated: 2017-02-03
Recalling firm: Medtec LLC
Product: Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
Product code: JAI Couch, Radiation Therapy, Powered
Reason for recall: When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
Root cause tag: software
FDA root cause: Software design
Action: Civco Medical Solutions sent a "Urgent Field Correction Notice" dated March 31, 2016, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer. The software's other configuration, "All 6 Degrees Protura" does not have the same translational issues. The firm send notification letters on February 23, 2016. In this letter, the Product Manager verified each site's software is configured to this operational mode which operates without the identified problem. In a later and separate notification on March 31, 2016, the firm informed customers that a new software version will be installed to address the problem. No timeframe was given in the letter. For further questions, please call ( 712) 737-8688.
Quantity in commerce: 9
Distribution: Worldwide Distribution - US Distribution including the countries of Switzerland, Germany..
Product codes and lots: Versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1992-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1992-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-15

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)