Reported Jun 22, 2016 · Terminated
Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and…
Med Tec Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Med Tec Inc · PO Box 320 · Orange City, IA · 51041-7463
Is this the product you have?
- 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
- Lot codes and dates
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)
- Amount recalled
- 9
Why it was recalled
When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
This product could cause temporary or reversible health problems — stop using it.
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