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Open, Classified

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.

FDA Recall Z-2453-2021 · Posted None

Recalling FirmAccora Inc
Recall StatusOpen, Classified
Product CodeINM
Date Initiated2021-06-21
Product Quantity122 (US); 270 (OUS)

Reason for Recall

The firm has identified a potential for the backrest to become detached from the chair.

Firm 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]

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

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

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