Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4

FDA device recall Z-2270-2023 · posted 2023-07-31 · Open, Classified

Recall details

Recalling firm

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Reason for recall

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.

Action taken

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 Acknowledgement and Receipt of Letter form to drodriguez@shimadzu-usa.com The National Technical Support phone number was provided: 844-487-2767

Root cause

Device Design

Status

Open, Classified

Product code

IYB

Quantity affected

1836

Distribution

U.S. Nationwide distribution.

Date initiated

2023-04-10

Date posted

2023-07-31

Location

Kyoto, Japan