510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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Z-2023-2014Class II

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

Invacare GmbH / initiated 2014-06-25 / Terminated / root cause: design

Invacare Corporation began a recall of Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2023-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Product code
INN Chair, Adjustable, Mechanical
Reason for recall
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.
Root cause tag
design
FDA root cause
Device Design
Action
The recall notification will be sent to the two consignees informing them of the recall and to notify their customers. The letter will include a provider letter, customer letter, provider response card and impacted units listing.
Quantity in commerce
465 units
Distribution
Distributed in PA and Canada.
Product codes and lots
Mobile Shower and Toilet commode Aquatec Ocean (Model # 1534327), Ocean VIP (Model # 1470713 and 1470793) and Ocean E-VIP (Model # 1525707).

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2023-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2023-2014Class IITerminatedVoluntary: Firm initiated