Recall Z-0534-2021 ยท IZL System, X-Ray, Mobile
Shimadzu Medical Systems
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.
| Date | Nov 9, 2020 |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Shimadzu issued a "Urgent: Voluntary Medical Device Recall Notice" on 11/09/2020" via email. In addition to informing consignees about the recalled device, the notification letter asked consignees to take the following actions: 1. If your unit is on the affected list, then please check the drive handle assembly to see if the bolts have loosened. If you feel there is a problem with the mobile drive and movement, please discontinue use of the system and contact your local service provider. 2. Shimadzu has identified the affected units and informed your authorized service representative. Th |
| Quantity | 115 units |
| Distribution | US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, ND, NE, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION Shimadzu Corp., May 14, 2008 |