GE HealthCare Medical Device Recall Report
Report ID: FMI18011
Product Information
Product Name: Medical Device X-ray Tube Component, Medical Angiography X-ray System
Manufacturer: General Electric Medical Systems (Shanghai) Co., Ltd.
Primary Brand: GE HealthCare
Recall Details
Recall Level: Level 3
Reason for Recall: Inaccurate Expected Service Life (ESL) description in technical documentation.
The technical reference manual for the Performix™ 160AX X-ray tube component and the operation manuals for associated medical angiography X-ray systems contained an inaccurate expected service life (ESL) value. The original calculation of 1833 kWh was based on a method that included system downtime, leading to an overestimation. GE HealthCare has re-calculated the ESL to be 2000 kWh, following the national standard GB 9706.228-2020.
Affected Products: Includes Performix™ 160AX X-ray tube component and various GE Medical Systems angiography X-ray systems such as Innova IGS series and Discovery IGS series.
Quantity Recalled (in China): 2152 units.
Corrective Actions
GE HealthCare will notify customers and provide a supplementary page for the Chinese manual containing the corrected information.
Note: This corrective action does not require the affected products to be taken out of service or returned.
Appendices
The document includes appendices listing detailed product information, registration numbers, and extensive identification codes for the affected units.
