Pentax Medical Company
Country not established FDA
- Devices
- 175
- Registrations
- FDA
- FDA recalls
- 30
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Pentax Medical Company makes
The company manufactures flexible and rigid endoscopic devices, including video colonoscopes (such as confocal and standard models), duodenoscopes, and bronchoscopes with integrated ultrasound capabilities. Products also include a confocal laser imaging system for real-time tissue examination and upper gastrointestinal scopes.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Search and filter all 175 devicesShowing 1-50 of 175
FDA recalls
FDA recall records list 30 recalls initiated by Pentax Medical Company, the earliest on 2011-09-30 and the most recent on 2016-04-06. By recorded status: 30 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 6 Apr 2016 Z-2065-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2066-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2067-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2068-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2069-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2070-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2071-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2072-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2073-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2074-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Show the 25 most recent of 30 recalls
2016
- 6 Apr 2016 Z-2075-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2076-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2077-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2078-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2079-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2080-2016 Class II Terminated Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 6 Apr 2016 Z-2275-2016 Class II Terminated Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
- 6 Apr 2016 Z-2276-2016 Class II Terminated Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
- 6 Apr 2016 Z-2277-2016 Class II Terminated Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
- 6 Apr 2016 Z-2278-2016 Class II Terminated Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
- 6 Apr 2016 Z-2279-2016 Class II Terminated Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
- 6 Apr 2016 Z-2280-2016 Class II Terminated Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
- 22 Feb 2016 Z-1835-2016 Class II Terminated Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
2014
- 17 Jul 2014 Z-2290-2014 Class II Terminated The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
Full distribution text
- 12 Jun 2014 Z-2116-2014 Class II Terminated Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
- 17 Jul 2014 Z-2290-2014 Class II Terminated The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
FDA establishments
- Pentax Medical Mississauga Ontario · CA FEI 3012414760
Frequently asked questions
How many devices does Pentax Medical Company have in the registry?
The registry currently lists 175 devices for Pentax Medical Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pentax Medical Company's devices?
Among its 50 most recently registered devices, Pentax Medical Company has devices listed in FDA GUDID (50 devices).
What risk classes do Pentax Medical Company's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Pentax Medical Company's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pentax Medical Company?
FDA recall records list 30 recalls initiated by Pentax Medical Company, the most recent initiated on 6 Apr 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Pentax Medical Company in the registry?
The most recently registered devices listed for Pentax Medical Company include PENTAX Medical EG29-i20c, PENTAX Medical EG27-i20c, PENTAX Medical EC38-i20cL and PENTAX Medical EC34-i20cL.
Which FDA establishments are linked to Pentax Medical Company?
1 FDA establishment is linked to Pentax Medical Company in the registry; they are listed on the company page.