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. 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. US and Mexico, Japan, Chile, Kuwait, Columbia, Hong Kong, China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles, British Virgin Islands,ġ A record in this database is created when a firm initiates a correction or removal action. The first dealer letter was sent via e-mail on July 7, 2016.ġ2,142 devices in US, 1,710 devices internationally. Dealers were then sent their list of Quickie Q7 wheelchairs that records show being sold by them and dealers are asked to return a list of chairs they are able to locate for correction. The firm began calling dealers to alert them to the recall and obtain primary contacts information. 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.
Were dedicated to not just meeting medical and clinical needs, but also quality-of-life needs.
At Quantum, consumer needs and wishes are the driving force. Please see spreadsheet provided in documents.R4-007239 to R4-022394. Quantum Rehab® was born out of the desire to delight customers with the most advanced, consumer-inspired complex rehab power wheelchairs and related technologies possible.
WHEELCHAIR SERIAL NUMBER LOOKUP SERIES
The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position. Class 2 Device Recall Quickie Q7 wheelchair.
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