The Recall Desk
HighFDA (Devices)·Z-1992-2016·Announced 2016-06-22

Med Tec Recalls Protura Robotic Couch System Software Due to Positioning Issues

Med Tec Inc is recalling specific versions of Protura Robotic Couch System Software because non-sub-millimeter positioning is inconsistent with settings in split shift mode.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Med Tec Inc is recalling Protura Robotic Couch System Software versions 1.6.1, 1.7.0, and 1.7.1. The recall involves nine units distributed worldwide, including in the United States, Switzerland, and Germany.

The recall was initiated because the software's non-sub-millimeter positioning has been found to be inconsistent with the setting parameters when the product is used in split shift mode. This inconsistency may affect the precision of the robotic couch system.

Healthcare facilities and users of the affected software should contact Med Tec Inc for instructions on how to resolve the issue. The source text does not specify a particular action such as a software update or replacement, but users should verify their software version against the affected part numbers (MT6XSM1.6.1, MT6XSM1.7.0, and MT6XSM1.7.1).

The recalled product

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
Manufacturer
Med Tec Inc
Category
Medical Device — Robotic Couch System
Hazard
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • 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)

Distribution

Distribution scope not specified by the agency.

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