Recall Z-1150-2014— Shimadzu Medical Systems
Class II · Terminated
Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2013-11-15, terminated 2015-06-25. It names one FDA 510(k) clearance: K001517. Product: Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency. Reason: 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..
- Recalling firm
- Shimadzu Medical Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-15
- Terminated
- 2015-06-25
- Firm location
- Torrance, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.