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Terminated

Quickie Q7 Adult Rigid Wheelchair Model EIR4.

FDA Recall Z-1020-2015 · Posted 2015-01-27

Recalling FirmSunrise Medical (US) LLC
Recall StatusTerminated
Product CodeIOR
Date Initiated2014-12-19
Date Terminated2015-03-10
Product Quantity6

Reason for Recall

There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.

Firm Action

Sunrise Medical sent an Urgent Medical Device Field Correction letters dated December 19, 2014 to the two affected distributors. The letter identified the affected product, problem and actions to be taken. For question contact Sunrise Medical Regulatory Affairs at either (559)294-2840.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution in the states of CO and ME.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123975QUICKIE & ZIPPIE SERIESSunrise Medical · 2013-08-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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