Generic Name: (1)-(2) Operating Table System (37325000) — (3)-(4) Column-type Operating Table System (36611000) — Trade Name: (1) Trusystem 7500 Mobile Operating Table — (2) Trusystem 7500 Mobile Operating Table — (3) Trusystem 7500 Fixed Operating Table — (4) Trusystem
TruSystem 7500 Operating Table Recall Summary TruSystem 7500 mobile and fixed operating tables (70 units total) are being recalled because a software defect can prevent the upper back section from adjusting properly when the emergency backup mode is activated. The problem only occurs if a component fails during normal use and the emergency mode must be used; normal operation is not affected. This recall affects hospitals and surgical facilities that received these tables between June 2012 and August 2025.
- Recalling firm
- Name of Manufacturer/Distributor: Central Uni Co., Ltd. — Address of Manufacturer/Distributor: 1-1 Maigaoka 5-chome, Kokuraminami-ku, Kitakyushu City, Fukuoka Prefecture — License Type: Type II...
- Product
- Lot: 改修対象総数：70台 （1）トルンプ手術台 TruSystem7500 移動型 機体番号：101626424、101839438、102046712、102046716、102050377、102050393 102084895、102457048、102689590、102703416、102710070、102715141 102715142、102715178、102715181、102722151、103543314、103546614 107360552、107832498、107964793、107971851、108001097、108044935 108368188 数 量： 25台 出荷時期：平成24年06月〜令和05年05月末 （2）TruSystem7500 移動型手術台 機体番号：109690827 数 量：1台 出荷時期：令和05年06月〜令和07年08月末 （3）トルンプ手術台 TruSystem7500 固定型 機体番号：101631699、102122603、102252230、102404110、102479871、102520425 102520427、102524855、102580907、102608642、102703408、102710076...
- Reason
- We have received a report from the overseas manufacturer stating that “when the emergency mode function is enabled, the upper back section of the Tabletop (U26) becomes inoperable (unadjustable), and it cannot be ruled out that this may prevent or delay the administration of appropriate medical treatment, potentially causing harm to patients.” Furthermore, the overseas manufacturer has decided to implement a software update to address this issue. Therefore, as the manufacturer and distributor in Japan, we have decided to implement the same measures.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/cb8e0c3e-7e18-4321-a85d-27d7aa1b84cb