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FUJIFILM
FUJIFILM CORPORATION · Model CA-601 · UDI-DI 04547410138511
1
510(k) clearances
4,015
Adverse events (23 deaths)
147
Recalls
396
Facilities
Description
This product is the cleaning adapter used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-17 | Sheathing Technologies Inc | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.