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Recall Observatory FDA recall evidence

Device product

Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.

Z-2023-2014

June 25, 2014

Class II

Product summary

Firm
Invacare Corporation
Event
Event 68399
Status
Terminated
Classification
Class II
Quantity
465 units
Official record key
device-enforcement:Z-2023-2014

Official wording

Reason: The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.

Code information: Mobile Shower and Toilet commode Aquatec Ocean (Model # 1534327), Ocean VIP (Model # 1470713 and 1470793) and Ocean E-VIP (Model # 1525707).

Distribution pattern: Distributed in PA and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.

Field note

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