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U.S. Department of Health and Human Services

Class 2 Device Recall Configura Advance Chair

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 Class 2 Device Recall Configura Advance Chairsee related information
Date Initiated by FirmJune 21, 2021
Create DateSeptember 13, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2453-2021
Recall Event ID 88441
Product Classification Chair, with casters - Product Code INM
ProductConfigura 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.
Code Information Serial Numbers (Domestically distributed) 10001-SC3-20 to 10115-SC3-20 10146-SC3-20 to 10235-SC3-20
FEI Number 3013254491
Recalling Firm/
Manufacturer		 Accora Inc
9210 Corporate Blvd Ste 120
Rockville MD 20850-6226
Manufacturer Reason
for Recall		The firm has identified a potential for the backrest to become detached from the chair.
FDA Determined
Cause 2		Device Design
ActionOn 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: info@accora.care
Quantity in Commerce122 (US); 270 (OUS)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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