Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Reported: June 8, 2016 Initiated: December 23, 2015 #Z-1860-2016
Product Description
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Reason for Recall
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- 1473 units
- Distribution
- Nationwide Distribution.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 1473 units.
Why was this product recalled? ▼
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2016. Severity: Moderate. Recall number: Z-1860-2016.
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