Fujifilm ED-530XT Endoscope Manual Correction for Infection Control
Fujifilm Medical Systems is correcting the ED-530XT endoscope manual to address reports of multi-drug resistant bacteria found on endoscopes used in 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 involves a high-risk pathogen (multi-drug resistant bacteria) and a medical device where infection risk is a significant concern, but the source text does not report specific hospitalizations or deaths, placing it in the High severity category per the rubric.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is issuing a correction for the ED-530XT Endoscope Operation Manual, specifically the 'Operation and Preparation' and 'Cleaning, Disinfection and Storage' sections. This action is a response to publicized reports of multi-drug resistant bacteria detected on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
The correction applies to 1,473 units of the manual that were distributed nationwide between March 2003 and April 2016. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
Healthcare facilities and users of the ED-530XT endoscope should review the corrected manual to ensure proper cleaning, disinfection, and storage protocols are followed to mitigate the risk of infection transmission.
The recalled product
- Product
- Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Endoscope
- Affected units
- 1,473
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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