Recall Z-0534-2021— Shimadzu Medical Systems
Class II · Ongoing
Class II FDA medical device recall by Shimadzu Medical Systems, initiated 2020-11-09. It names one FDA 510(k) clearance: K080701. Product: Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.. Reason: There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device..
- Recalling firm
- Shimadzu Medical Systems
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-11-09
- 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
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Reason for recall
There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. This could result in improper driving operation which could lead to harm of individuals around the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.