Fujifilm ED-450XT5 Endoscope Manual Correction for Infection Risk
Fujifilm Medical Systems is correcting the ED-450XT5 endoscope manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (endoscope) where injury has not yet been reported in the source text, fitting the 'High' severity criteria for high-risk pathogens or theoretical harm.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is issuing a correction for the Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage. This action is a response to publicized reports of multi-drug resistant bacteria found on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
The correction affects 484 units of the manual that were distributed nationwide between March 2003 and April 2016. The agency has classified this recall as Class II, indicating that use of or exposure to the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and users of the ED-450XT5 endoscope should review the corrected manual to ensure proper cleaning, disinfection, and storage protocols are followed to mitigate the risk of infection.
The recalled product
- Product
- Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Endoscope
- Affected units
- 484
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 distribution dates :3/2003-4/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Fujifilm Medical Systems U.S.A., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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