Aizu Olympus Co., Ltd.
AIZUWAKAMATSU-SHI Fukushima, JP
AIZU OLYMPUS CO., LTD. appears in FDA device records in AIZUWAKAMATSU-SHI Fukushima, JP. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 31 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Aizu Olympus Co., Ltd. in 2005.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610595 | 3002964398 | AIZU OLYMPUS CO., LTD. | 3-1-1 Niiderakita, AIZUWAKAMATSU-SHI Fukushima 965-8520 JP | 2026 | and 18 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNLAccessories, Cleaning Brushes, For Endoscope
- FEBAccessories, Cleaning, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- EOQBronchoscope (Flexible Or Rigid)
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FDFColonoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- FBOCystourethroscope
- FDTDuodenoscope And Accessories, Flexible/Rigid
- ODCEndoscope Channel Accessory
- NWBEndoscope, Accessories, Narrow Band Spectrum
- MNKEndoscopic Bite Block
- OCXEndoscopic Irrigation/Suction System
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FDAEnteroscope And Accessories
- FDSGastroscope And Accessories, Flexible/Rigid
- HIHHysteroscope (And Accessories)
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- NTNLed Light Source
- EOBNasopharyngoscope (Flexible Or Rigid)
- EQHSource, Carrier, Fiberoptic Light
- PGUSpatial Imaging For Display Of Endoscope Position
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
Showing 25 of 31| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0874-2026 | Olympus OER-Mini | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. | Class II | Open, Classified | |
| Z-0873-2026 | Olympus OER-Pro | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. | Class II | Open, Classified | |
| Z-0872-2026 | Olympus OER-Elite | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. | Class II | Open, Classified | |
| Z-0419-2024 | PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection. | Class II | Open, Classified | |
| Z-0418-2024 | PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection. | Class II | Open, Classified | |
| Z-0417-2024 | GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection. | Class II | Open, Classified | |
| Z-0416-2024 | GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection. | Class II | Open, Classified | |
| Z-0415-2024 | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection. | Class II | Open, Classified | |
| Z-0348-2024 | Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0347-2024 | Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0346-2024 | Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0345-2024 | Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0344-2024 | Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0343-2024 | Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion. - Model Number: SIF-Q180. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0342-2024 | Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0341-2024 | Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0340-2024 | Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0339-2024 | Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0338-2024 | Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0337-2024 | Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0336-2024 | Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0335-2024 | Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0334-2024 | Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0333-2024 | Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified | |
| Z-0332-2024 | Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain