Z-0506-2021Class II

Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 -

Name: Z-0506-2021 Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 -
Creator: Olympus Corporation of the Americas
Published: 2020-10-16
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2020-10-16 / Terminated / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body on 2020-10-16. FDA classified it as Class II and gives the reason as "A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0506-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-16
Posted: 2020-11-27
Terminated: 2022-06-07
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Product code: ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Reason for recall: A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Root cause tag: design
FDA root cause: Device Design
Action: Our records indicate that your facility has purchased one or more of the affected GF-UCT140-AL5 endoscopes/GF-UC140P-AL5 endoscopes/EUS endoscopes. OMSC requests you to take the following actions: 1. Inspect your inventory for the referenced devices and identify any device with the model number specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. The model number can be found on the device as illustrated in the following picture. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum. This Addendum contains the instructions on how to determine if there is a full blockage of the air/water channel. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the new inspection steps. The new inspection steps are performed immediately after the clinical procedure and prior to endoscope reprocessing. 4. After November 2020 additional copes of the new Operation Manuals can be obtained by accessing our OlympusConnect site and downloading a copy of the new Manuals. Please visit our OlympusConnect customer website: at https://OlympusConnect.com. New users will need to register. Once registered select [Product Support] on the left navigation bar, then select [Operation Manuals], locate the Model name. 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0XXX and provide your contact information as indicated in the portal. 6. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. If you require additional information about the new inspection steps, you can obtain additional information as follows: You can contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. The TAC department can assist you in ans
Quantity in commerce: 49
Distribution: Worldwide distribution - US Nationwide distribution. Model Name ------------ Quantity distributed in U.S. GF-UC140P-AL5 ------------- 1,297 devices GF-UCT150-AL5 ------------- 564 devices GF-UCT180 -------------------- 3,145 devices GF-UM20 ----------------------- 31 devices GF-UM130 --------------------- 27 devices GF-UMQ130 ------------------- 373 devices GF-UM160 --------------------- 299 devices GF-UC160P-OL5 ------------- 46 devices GF-UCT160-OL5 ------------- 49 devices GF-UE160-AL5 -------------- 2,691 devices
Product codes and lots: All Serial/Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0506-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0498-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27
Z-0499-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27
Z-0500-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27
Z-0501-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27
Z-0502-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27
Z-0503-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27
Z-0504-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27
Z-0505-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27
Z-0506-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27
Z-0507-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-11-27

Product code ODG

K010591Class IIOlympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. / cleared 2001-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)