FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33
Reported: June 5, 2024 Initiated: April 11, 2024 #Z-1898-2024
Product Description
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33
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
Details
- Recalling Firm
- FUJIFILM Healthcare Americas Corporation
- Units Affected
- 18 units
- Distribution
- US Nationwide distribution in the states of AK, CA, FL, IL, NE, NH, OH, TN, WI.
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33. Recalled by FUJIFILM Healthcare Americas Corporation. Units affected: 18 units.
Why was this product recalled? ▼
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2024. Severity: Moderate. Recall number: Z-1898-2024.
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