Generic Name: Anesthesia System — Trade Name: (1) Carestation 600 Series — (2) Carestation 750 Series
Recall Summary Carestation 600 and 750 Series anesthesia systems are being recalled because a power management component may fail to switch to battery backup during a power outage, potentially causing the system to shut down unexpectedly. This could temporarily interrupt anesthesia gas delivery and ventilation settings, which would need to be manually reset. The recall affects 77 units of the Carestation 600 Series and 8 units of the Carestation 750 Series distributed between June 2019 and October 2025. No patient injuries have been reported, and the manufacturer notes these devices are always used under medical staff supervision.
- Recalling firm
- Name of Manufacturer/Distributor: GE Healthcare Japan Co., Ltd. — Address of Manufacturer/Distributor: 4-7-127 Asahigaoka, Hino City, Tokyo — Type of License: Class I Medical Device...
- Product
- Lot: （１）Carestation 600 シリーズ 製造番号 ： ANE001421、ANE001969、ANE001970、ANE001971、ANE001972、ANE001973、ANE001974、 ANE001975、ANE001976、ANE001977、ANE001978、ANE001981、ANE001982、ANE001983、 ANE001998、ANE002004、ANE002005、ANE002006、ANE002008、ANE002009、ANE002010、 ANE002011、ANE002012、ANE002013、ANE002014、ANE002015、ANE002016、ANE002017、 ANE002018、ANE002019、ANE002020、ANE002021、ANE002022、ANE002023、ANE002025、 ANE002026、ANE002027、ANE002028、ANE002031、ANE002032、ANE002033、ANE002034、 ANE002035、ANE002036、ANE002037、ANE002039、ANE002040、ANE002041、ANE002042、...
- Reason
- According to a report from the manufacturer, it has come to light that, in certain power management boards (PMBs) installed in the affected devices, the device may fail to automatically switch to battery power when the AC mains power is disconnected or a power failure occurs, potentially resulting in unexpected shutdowns and reboots. Therefore, based on information from the manufacturer, we are providing information regarding this issue and will perform corrective work on the affected devices, including replacement with software and hardware that has been updated to resolve the problem.
- 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/4c922040-2a15-4f57-b984-76c0340ea8a7