Recall Z-0451-2016— Shimadzu Medical Systems
Class II · Terminated
Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2015-11-10, terminated 2016-10-27. It names one FDA 510(k) clearance: K080701. Product: Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.. Reason: The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly..
- Recalling firm
- Shimadzu Medical Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-10
- Terminated
- 2016-10-27
- 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 MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
Reason for recall
The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.