Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
FDA device recall Z-2023-2014 · posted 2014-07-09 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- INN
- Quantity affected
- 465 units
- Distribution
- Distributed in PA and Canada.
- Date initiated
- 2014-06-25
- Date posted
- 2014-07-09
- Date terminated
- 2015-04-15
- Location
- Elyria, OH
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