Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography o
FDA device recall Z-1369-2013 · posted 2013-06-03 · Terminated
Recall details
- Recalling firm
- Shimadzu Medical Systems
- Reason for recall
- The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G. As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.
- Action taken
- Shimadzu sent a recall letter dated March 18, 2013, to all customers who purchased the Shimadzu MobileDart Evolution in combination with CXDI-70C, CXDI-55C, or CXDI-55G. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to follow the instructions of the recall notice step by step. Customers with questions are instructed to contact their local Shimadzu representatives or contact Shimadzu National Technical Support at (800) 228-1429. A Field Safety Notice dated March 18, 2013, was sent to Service Managers in regards to the Shimadzu Mobile DaRt Evolution in combination with CXDI-70C, CXDI-55C, or CXDI-55G. The Safety Notice informs the Service managers of the problems identified and the actions to be taken.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 200 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2013-03-18
- Date posted
- 2013-06-03
- Date terminated
- 2014-02-13
- Location
- Torrance, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION (K080701) | Shimadzu Corp. | 2008-05-14 |