FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, ches
FDA device recall Z-1898-2024 · posted 2024-05-24 · Open, Classified
Recall details
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Reason for recall
- Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
- Action taken
- FUJIFILM Healthcare Americas Corporation (FUJIFILM) issued Urgent -FIrst Notice letter via email on 4/11/24. Letter states reason for recall, health risk and action to take: 1)Please complete and return the form attached on page 3 of this communication. Providingthe response with the information requested is essential for ensuring appropriate action istaken 2)Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to open a serviceticket. 3)Until your upgrade is scheduled and completed, you can continue to safely use FDRVisionary Suite, however, inspect the bolts prior to use. Please contact our field action coordinator, Chaitrali Kulkarni, via email at hcusregulatoryaffairs@fujifilm.com, if you have any further questions regarding this field action.
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- KPR
- Quantity affected
- 18 units
- Distribution
- US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
- Date initiated
- 2024-04-11
- Date posted
- 2024-05-24
- Location
- Lexington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FDR Visionary Suite (K152294) | Shimadzu Corporation | 2016-07-15 |