FDA Medical Device Recalls (openFDA)
Pentax of America Inc: Video Cytoscopes
- Recall number
- Z-2325-2017
- Recalling firm
- Pentax of America Inc
- Product
- Video Cytoscopes
- Status
- Terminated
- Initiated
- 2011-01-11
- Posted
- not on file
- Terminated
- 2018-03-13
- Reason
- This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
- Root cause
- Device Design
- Action
- Customers were visited by members of Pentax America, Inc. field service team. The field service technicians inspected the affected devices, and documented the inspections using the Inspection Record Form (QS-397).
- Quantity
- 1,349 - (Total - US) and 352 (Total - OUS)
- Distribution
- US Nationwide and Internationally
- Lot, serial or model codes
- Model #'s:ECY-1570 and ECY-1570K
- 510(k) numbers
- ["K131028","K131946"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 1000080301
- Firm city
- Montvale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28