Device recall: Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
Class II FDA enforcement event 73088. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Integrated Medical Systems Inc started this device recall on 20 Jan 2016. The firm address in the FDA record is in Birmingham, AL. FDA put the recall in Class II. FDA event 73088 has 22 product records. The first FDA enforcement report date is 2 Mar 2016. The record gives the status Terminated, with the termination date 13 Oct 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed US (nationwide) and in Australia.
Recalling firm
Integrated Medical Systems Inc, Birmingham, AL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
22 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0889-2016 | Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope | 190 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0890-2016 | Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope | 275 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0891-2016 | Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope | 232 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0892-2016 | Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope | 111 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0893-2016 | Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope | 180 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0894-2016 | Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope | 185 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0895-2016 | Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope | 21 devices | Class II | Terminated | 2 Mar 2016 |
| Z-0896-2016 | Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope | 82 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0897-2016 | Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope | 5 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0898-2016 | Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope | 26 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0899-2016 | Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope | 9 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0900-2016 | Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope | 12 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0901-2016 | Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope | 122 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0902-2016 | Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope | 43 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0903-2016 | Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope | 9 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0904-2016 | Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope | 54 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0905-2016 | Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope | 16 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0906-2016 | Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope | 4 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0907-2016 | Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope | 3 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0908-2016 | Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope | 1 instrument | Class II | Terminated | 2 Mar 2016 |
| Z-0909-2016 | Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope | 2 instruments | Class II | Terminated | 2 Mar 2016 |
| Z-0910-2016 | Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope | 1 instrument | Class II | Terminated | 2 Mar 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 22
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0889-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 73088. https://recallregister.com/fda/ii/73088/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed US (nationwide) and in Australia.
- What quantity of product is in FDA event 73088?
- The event has 22 product records. The first record gives this quantity:
190 instruments
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.