Recall Z-2113-2012— Sunrise Medical (US) LLC

Name: FDA recall Z-2113-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-26

Class II · Terminated

Class II FDA medical device recall by Sunrise Medical (US) LLC, initiated 2012-06-26, terminated 2012-11-01. It names one FDA 510(k) clearance: K973673. Product: Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.. Reason: Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm..

Recalling firm: Sunrise Medical (US) LLC
Classification: Class II
Status: Terminated
Initiated: 2012-06-26
Terminated: 2012-11-01
Firm location: Fresno, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K973673 — QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIESSunrise Medical, Inc.·cleared 1997-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.

Reason for recall

Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.

Data sourced from openFDA. This site is unofficial and independent of the FDA.