Device product
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Z-0138-2017
Product summary
- Event
- Event 74542
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2, 686 units
- Official record key
device-enforcement:Z-0138-2017
Official wording
Reason: New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
Code information: Model: OER-Pro, All serial numbers affected
Distribution pattern: Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
Derived failure modes
-
Unknown
New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.