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
FDA Recall Z-1992-2016 · Posted None
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Recalling FirmMed Tec Inc
Recall StatusTerminated
Product CodeJAI
Date Initiated2016-03-31
Date Terminated2017-02-03
Product Quantity9
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Distribution including the countries of Switzerland, Germany..
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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