Z-1034-2022Class II

Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging

Name: Z-1034-2022 Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging
Creator: Olympus Corporation of the Americas
Published: 2022-03-18
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-03-18 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging on 2022-03-18. FDA classified it as Class II and gives the reason as "GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1034-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-18
Posted: 2022-05-05
Recalling firm: OLYMPUS Corporation of the Americas
Product: Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Root cause tag: design
FDA root cause: Device Design
Action: Olympus issued URGENT: MEDICAL DEVICE CORRECTIVE ACTION on 3/18/22. Letter states reason for recall, health risk and action to take: 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. If you are using the OER-Pro for high level disinfection of the GF-UC140P-AL5, please transition to an OER-Elite or another AER validated for GF-UC140P-AL5 reprocessing as soon as possible. 3. When manually cleaning the GF-UC140P-AL5 carefully follow the instructions in the IFU, vigilantly cleaning all channels and the forceps elevator. Ensure that you are inspecting the GFUC140P-AL5 prior to each use and after each use according to the instructions. 4. Ensure all personnel understand that the GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and further that such personal are completely knowledgeable and thoroughly trained on the Instructions for Use applicable to the GF-UC140P-AL5 device 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0406 and provide your contact information as indicated in the portal. If you require additional information about the GF-UC140P-AL5 reprocessing, you can obtain additional information as follows: You can contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1 and the TAC department can assist you in answering questions. OMSC requests you to report any patient injuries, including infections or persistent microbial colonization associated with any OMSC endoscope. Call our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1 to report complaints.
Quantity in commerce: 731 units
Distribution: Nationwide
Product codes and lots: All serial numbers. GTIN: 04953170356322

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1034-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1034-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-11	2022-05-05

Product code ITX

K011314Class IIOlympus Gf Uc140p-Al5 Ultrasonic Endoscope with Aloka Ssd-5500 Ultrasound SystemAloka Co., Ltd. / cleared 2001-05-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)