Fujifilm Recalls 362 Fujinon ED-530XT Endoscopes for Reprocessing Risk
Fujifilm Medical Systems is recalling 362 Fujinon ED-530XT endoscopes nationwide to reduce patient risk from inadequate reprocessing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (inadequate reprocessing) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 362 units of the FUJINON ED-530XT endoscope. This medical device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
The recall was initiated to implement an update to the design and labeling to help reduce patient risk associated with inadequate reprocessing of the device. The corrective action includes the replacement of the forceps elevator mechanism, the O-ring seal, and the distal end cap, as well as the issuance of a new Operation Manual.
The recall covers all lots and serial numbers of the affected units, which were distributed nationwide. The source text does not specify specific instructions for consumers or healthcare providers beyond the description of the corrective actions.
The recalled product
- Product
- FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 362
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots/serial numbers
Distribution
Distributed nationwide across the United States.
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