When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame. There is an observed failure of the backrest bracket which can fatigue over the life time of the product. Please see spreadsheet provided in documents.R4-007239 to R4-022394. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = IOR and Original Applicant = SUNRISE MEDICAL, INC.Class 2 Device Recall Quickie Q7 wheelchair. 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. Worldwide Distribution - United States and Canada.ġ A record in this database is created when a firm initiates a correction or removal action. Questions should be directed towards their dealer or Sunrise Medical at 80. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. The letter identified the affected product and the reason for the recall. The stabilizer bar was inadvertently omitted during the manufacturing process.Īn Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States Canadian consignees were notified via e-mail. Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat. Product is manufactured and distributed by Sunrise Medical, Inc. Manual Wheelchairs with Transit System Option, Class 2 Device Recall Manual Wheelchairs with Transit System Option
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