Recall Z-0044-2026— FUJIFILM Healthcare Americas Corporation
Class II · Ongoing
Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2025-09-15. It names one FDA 510(k) clearance: K152294. Product: FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33. Reason: It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting..
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-15
- Firm location
- Lexington, MA, United States
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
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Reason for recall
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Data sourced from openFDA. This site is unofficial and independent of the FDA.