Recall Z-0550-2025— GE Healthcare (China) Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare (China) Co., Ltd., initiated 2024-10-24. It names one FDA 510(k) clearance: K993090. Product: GE Proteus XR/A radiographic system. Reason: Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List..
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-24
- Firm location
- Beijing, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GE Proteus XR/A radiographic system
Reason for recall
Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
Data sourced from openFDA. This site is unofficial and independent of the FDA.