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Ultrasound Bronchoscope recallZ-2076-2016 · Pentax Medical Company · initiated Apr 6, 2016

Class II Terminated All recalls posted in June 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Pentax Medical Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.

Recall details

Recall number
Z-2076-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 6, 2016
Posted by the FDA
Jun 28, 2016
Recalling firm
Pentax Medical Company
Quantity
115 units
Product code
EOQ
FDA submissions
K023376, K131028, K951199
Distribution
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Product description

Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations

Code information (models, lots, serial numbers)

Model #EB-1970UK

Other devices under the same FDA submission

13 devices cleared under K023376, K131028, K951199 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 73894).

Sources and updates

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