AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which al
FDA device recall Z-1583-2015 · posted 2015-05-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.
- Action taken
- The firm, Siemens Healthcare, sent a "Safety Advisory Notice" dated April 14, 2015, to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization making them aware of the problem; and forward this safety information to other organizations that could be affected. If the device has been sold and therefore no longer in your possession, forward the safety notice to the new owner. Additionally, customers were instructed observe this safety notice and comply with the corresponding measures until the update has been fully completed. If you have any questions, contact customer support at 610-219-6300.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 43
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-04-14
- Date posted
- 2015-05-05
- Date terminated
- 2016-08-17
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) (K013826) | Siemens Medical Systems, Inc. | 2002-02-01 |