The Recall Desk
HighFDA (Devices)·Z-0341-2024·Announced 2023-11-29

Colonoscopes recalled over unvalidated channel drying process

Aizu Olympus colonoscopes are being recalled because the air drying process for the instrument channel was not properly validated. Some units returned after repair had moisture in the channel, creating a risk of contamination and infection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving an unvalidated channel air drying process. Some units returned to customers contained moisture that could lead to contamination and infection, though no actual infections have been reported. Per the rubric, risk-of-harm medical devices without reported injury score as High (3).

Plain-English summary

Aizu Olympus Co., Ltd. is recalling 3,101 colonoscope units due to an unvalidated channel air drying process. These instruments are indicated for use in the lower digestive tract and must be properly dried after sterilization.

The air drying process for the instrument channel was not properly validated. Some colonoscopes returned to customers after repair contained moisture remaining in the channel. This water creates a potential for contamination that could lead to infection.

The recalled models are being distributed to customers nationwide. Healthcare facilities and providers should identify whether they have received affected units among the following 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, and PCF-S.

Healthcare providers who have received these colonoscopes should contact Aizu Olympus Co., Ltd. to determine if their equipment is affected and to arrange for appropriate corrective action.

The recalled product

Product
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
Manufacturer
Aizu Olympus Co., Ltd.
Category
Medical Device — Endoscopy / Diagnostic Equipment
Hazard
  • moisture-contamination
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 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).

Distribution

Distributed nationwide across the United States.

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