Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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
FDA enforcement reports joined to recall event Z-2453-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2453-2021Class IIOngoingVoluntary: Firm initiated