Z-1020-2015Class II
Quickie Q7 Adult Rigid Wheelchair Model EIR4
Sunrise Medical, Inc. / initiated 2014-12-19 / Terminated / root cause: design
Sunrise Medical (US) LLC began a recall of Quickie Q7 Adult Rigid Wheelchair Model EIR4 on . FDA classified it as Class II and gives the reason as "There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1020-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Sunrise Medical, Inc.
- Product
- Quickie Q7 Adult Rigid Wheelchair Model EIR4.
- Product code
- IOR Wheelchair, Mechanical
- Reason for recall
- There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
- Root cause tag
- design
- FDA root cause
- Device Design
- 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.
- Quantity in commerce
- 6
- Distribution
- Nationwide Distribution in the states of CO and ME.
- Product codes and lots
- Serial numbers: R4-025066, R4-025051, R4-025010, R4-024771, R4-024738, R4-024649.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1019-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1020-2015 | Class II | Terminated | Voluntary: Firm initiated |
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