Z-1080-2014Class II
Siemens Artis zee Ceiling Systems. Angiographic x-ray system
Siemens Medical Solutions USA, Inc. / initiated 2013-12-16 / Terminated / root cause: design
Siemens Medical Solutions USA, Inc began a recall of Siemens Artis zee Ceiling Systems. Angiographic x-ray system on . FDA classified it as Class II and gives the reason as "During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1080-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
- Product code
- IZI System, X-Ray, Angiographic
- Reason for recall
- During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- In December 2013, a recall notification letter was sent to Users.
- Quantity in commerce
- 284
- Distribution
- Nationwide Distribution.
- Product codes and lots
- Artis zee Ceiling systems serial numbers from 146352 to 147617
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1080-2014 | Class II | Terminated | Voluntary: Firm initiated |
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