High FDA (Devices)·Z-3082-2017·Announced 2017-09-06

Med Tec Rigid Arm Supports Recalled for Height Dimensional Variance

Med Tec Inc is recalling 101 Rigid Arm Supports used in Posiboard-2 and Posirest systems due to a potential 17mm height difference.

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 dimensional defect in a medical device used for patient positioning during radiotherapy, which poses a risk of harm without reported injuries.

Plain-English summary

Med Tec Inc is recalling 101 units of Rigid Arm Supports (REF 106015) that were distributed between October 2009 and July 2012. These components are utilized on Posiboard-2 and Posirest assemblies, which are intended to position patients' upper extremities during breast and lung diagnostic and radiotherapy treatment. The affected products were distributed under various part numbers, including 106015, 106047, 106521, 106522, 109030, and 109040.

The recall was initiated because the Rigid Arm Supports may have a height difference of approximately 17mm. This dimensional variance could affect the intended positioning of the patient's upper extremities during medical procedures. The agency has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The affected units were distributed worldwide, including to the United States (specifically Michigan, Illinois, and Texas) and numerous international locations such as Greece, Australia, the Czech Republic, and others. Healthcare facilities and distributors should stop using these specific arm supports and contact Med Tec Inc for further instructions on the recall process.

The recalled product

Product: CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Po
Manufacturer: Med Tec Inc
Category: Medical Device — Radiotherapy Positioning
Hazard: dimensional-defect
patient-positioning
Affected units: 101

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 (20)

Codes: M207190
M212200
M141830
M142280
M144220
M149540
M149550
M149560
M149580
M164440
M164470
M177290
M177330
M177340
M198070
M198100
M285840
M133130
M137690
M138630

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 recalled by Med Tec Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Med Tec Inc

See all →

High
Med Tec Type S Extension Recalled for Potential Disengagement Risk
FDA (Devices) · 2020-06-10
High
CIVCO Solstice SRS Immobilization System Recalled for Potential Movement
FDA (Devices) · 2019-06-26
High
Med Tec Protura Software Recalled for Pedestal Coordinate Errors
FDA (Devices) · 2018-02-28
Moderate
Med Tec Recalls CIVCO Rigid Arm Supports for Height Discrepancy
FDA (Devices) · 2017-09-06
High
Med Tec Recalls Protura Robotic Couch System Software Due to Positioning Issues
FDA (Devices) · 2016-06-22

Same hazard · dimensional defect