Recall Z-2453-2021 ยท INM Chair, With Casters
Accora Inc
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 10
| Date | Jun 21, 2021 |
| Status | Open, Classified |
| Reason | The firm has identified a potential for the backrest to become detached from the chair. |
| 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 Saf |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.