Generic Name: General-purpose Diagnostic Imaging System Workstation Trade Name: Xyostation Revolus Rl

Summary Xyosoft Corporation is recalling 76 Xyostation Revolus RL diagnostic imaging workstations manufactured between March 2023 and January 2026 due to a software bug that resets manually corrected heart valve analysis measurements back to automatic values after certain operations. While this could potentially lead to incorrect diagnoses or treatment, the company states that doctors typically use multiple clinical indicators to confirm diagnoses and no patient injuries have been reported.

Recalling firm

Name of manufacturer and distributor: Xyosoft Corporation Location of manufacturer and distributor: Mita Kokusai Building, 4-28, Mita 1-chome, Minato-ku, Tokyo Type of license: Type 1 medical...

Product

Lot: Ser.No：以下の通り RL230005A, RL230028A, RL230046S, RL230055A, RL230027A, RL230071A, RL230094S, RL230107A, RL230116S, RL230118S, RL230119S, RL230128A, RL230172S, RL230182A, RL240009S, RL240017A, RL230181A, RL240041A, RL240063A, RL240064A, RL240077S, RL240104A, RL240108A, RL240111A, RL240100A, RL240129S, RL240110A, RL240115A, RL240132A, RL240148S, RL240119A, RL240151A, RL240170S, RL240147S, RL240189S, RL240146A, RL240154A, RL240173A, RL240181A, RL240203A, RL240194A, RL240200A, RL240212A, RL240167A, RL240213A, RL240206A, RL240221A, RL240214A, RL250007A, RL240136A, RL250008A, RL240233A,...

Reason

In a specific software version of this system, a bug was found that the manually corrected "coronary artery height" value in the heart valve analysis option was reset to the automatically extracted value after a specific operation. Therefore, we have decided to correct the software as a voluntary modification.

Classification

Class II

Category

medical device recall

Country

Japan

Agency

PMDA-DEVICE

Recall date

2026-02-20

Status

Ongoing

Official recall notice from PMDA-DEVICE

Recall details on Nibble Recalls: https://trynibble.app/recalls/ff6de276-6568-4da5-9218-8802bab257b2