CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report
Colonoscope-indicated for use within the lower digestive recalled
Aizu Olympus Co is recalling Colonoscope-indicated for use within the lower digestive tract (including the anus, distributed nationwide in the US. The recall was initiated on 25 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0341-2024
- FDA event ID
- 93222
- Recalling firm
- Aizu Olympus Co, Aizuwakamatsu, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Sep 2023
- FDA classified
- 17 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 25 Sep 2023 | Recall initiated by company | |
| 17 Nov 2023 | Classified by FDA | +53 days |
| 29 Nov 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Is Colonoscope-indicated for use within the lower digestive tract (including the anus recalled?
Yes. Aizu Olympus Co recalled Colonoscope-indicated for use within the lower digestive tract (including the anus on 25 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0341-2024.
Why was it recalled?
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
Which lots are affected?
Model Number (UDI-DI): PCF-H180AI (04953170339875), PCF-H180AL (04953170339899), PCF-H190DI (04953170363696), PCF-H190DL (04953170363672), PCF-H190I (04953170305214), PCF-H190L (04953170305191), PCF-H190TI (04953170420719), PCF-H190TL (04953170420702), PCF-HQ190I (04953170416132), PCF-HQ190L (04953170416118), PCF-PH190I (04953170305252), PCF-PH190L (04953170305238), PCF-Q180AI (04953170307713), PCF-Q180AL (04953170307720), PCF-S (04953170339912).
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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