Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take genera
FDA device recall Z-1150-2014 · posted 2014-03-07 · Terminated
Recall details
- Recalling firm
- Shimadzu Medical Systems
- Reason for recall
- Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis and the column of MUX-100 may crack.
- Action taken
- A Field Safety Notice and an Urgent Voluntary Medical Device Recall Notice were sent to customers to inform them that SHIMADZU CORPORATION has identified a potential issue in certain manufacturing lots of the Shimadzu Mobile X-ray Systems. Customers are informed that as a result of their investigation, it has been learned that the connecting work of very few column used in specific lots for the MUX series was not done correctly, and it may cause a crack. Therefore, if the machine is continuously used in that condition, there is the possibility that the column will start to lean. The notices informs the customers of the actions to be taken. Customers are instructed to contact Shimadzu Medical Systems National Technical Support at (800) 228-1429.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 56 units
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2013-11-15
- Date posted
- 2014-03-07
- Date terminated
- 2015-06-25
- Location
- Torrance, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES (K001517) | Shimadzu Corp. | 2000-06-27 |