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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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.
Related recalls
Same manufacturer · Med Tec Inc
See all →- HighMed Tec Type S Extension Recalled for Potential Disengagement Risk
FDA (Devices) · 2020-06-10
- HighCIVCO Solstice SRS Immobilization System Recalled for Potential Movement
FDA (Devices) · 2019-06-26
- HighMed Tec Protura Software Recalled for Pedestal Coordinate Errors
FDA (Devices) · 2018-02-28
- ModerateMed Tec Recalls CIVCO Rigid Arm Supports for Height Discrepancy
FDA (Devices) · 2017-09-06
- HighMed Tec Rigid Arm Supports Recalled for Height Dimensional Variance
FDA (Devices) · 2017-09-06
Similar recalls
- HighMed Tec Protura Software Recalled for Pedestal Coordinate Errors
FDA (Devices) · 2018-02-28
- ModerateZimmer Biomet Recalls MEDTECH ROSA Spine Software Due to Unapproved Change
FDA (Devices) · 2017-04-19
- HighHitachi PROBEAT-V Proton Therapy System Software Recall
FDA (Devices) · 2019-07-03
- HighElekta Monaco Radiation Treatment Planning System Software Recall
FDA (Devices) · 2019-08-07
- HighBrainlab ExacTrac 6.x Software Recalled for Potential Positioning Errors
FDA (Devices) · 2015-05-13
- HighMedtronic SynchroMed II and III Implantable Pumps Recalled for Software Defects
FDA (Devices) · 2025-01-08