Z-2453-2021Class II
Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual...
Accora Ltd / initiated 2021-06-21 / Open, Classified / root cause: design
Accora Inc began a recall of Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20... on . FDA classified it as Class II and gives the reason as "The firm has identified a potential for the backrest to become detached from the chair". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2453-2021
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Accora Ltd
- Product
- Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20. Model Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.
- Product code
- INM Chair, With Casters
- Reason for recall
- The firm has identified a potential for the backrest to become detached from the chair.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- On June 21, 2021, the firm sent affected customers Urgent Field Safety Notices via email. The notice identified the affected products and informed customers of the product issue. The corrective action will be to fit a modification kit to eliminate this fault condition and ensure the backrest cannot detach from the chair. All new production chairs will have this kit fitted as standard. Customers should make sure that all caregivers and users of the affected Configura Advance Chair devices are made aware of this Field Safety Notice. Furthermore, they should contact Accora to arrange a Field Safety Corrective Action kit to be installed on each product. This will be fitted free of charge. If you have questions or require assistance, please contact Accora: Accora Limited, Charter House, Barrington Road, Orwell, Cambridge SG8 5QP T: +44 (0)1223 206100 E: [email protected]
- Quantity in commerce
- 122 (US); 270 (OUS)
- Distribution
- Worldwide distribution - US Nationwide in the states of AL, FL, IL, MN, MS, NH, NJ, NY, NC, OH, PA, SC and the countries of Ireland, UK, and Australia.
- Product codes and lots
- Serial Numbers (Domestically distributed) 10001-SC3-20 to 10115-SC3-20 10146-SC3-20 to 10235-SC3-20
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2453-2021 | Class II | Ongoing | Voluntary: Firm initiated |
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