Recall Z-2270-2023 ยท IYB Tube Mount, X-Ray, Diagnostic
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
| Date | Jul 31, 2023 (initiated Apr 10, 2023) |
| Status | Open, Classified |
| Reason | Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling. |
| Root cause | Device Design |
| Action | On 4/10/23, recall notices were emailed to customers who were asked to do the following: 1)The Tube Column Assembly is secured by eight fixing bolts located at the base of the assembly. If while using the system, you observe loose, or missing bolts then please discontinue use of the system and call your authorized Service Provider. 2) Schedule a time with their Distributer to have their system updated. 3) Post the notice within their facility so that all users are aware of how to avoid this issue until the corrective actions has been completed. 4) Complete and return the Customer Acknowledgeme |
| Quantity | 1836 |
| Distribution | U.S. Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.