Z-1929-2017Class II

Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A...

Name: Z-1929-2017 Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A...
Creator: Olympus Corporation of the Americas
Published: 2017-02-10
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2017-02-10 / Terminated / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable... on 2017-02-10. FDA classified it as Class II and gives the reason as "A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1929-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-10
Posted: 2017-02-21
Terminated: 2018-05-09
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603
Product code: HET Laparoscope, Gynecologic (And Accessories)
Reason for recall: A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
Root cause tag: design
FDA root cause: Device Design
Action: A letter to consignees was sent February 10, 2017. Olympus will be repairing the device at user sites by disabling the temperature sensor.
Quantity in commerce: 863 units
Distribution: Nationwide
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1929-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1929-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-03

Product code HET

K111788Class IIEndoeye Hd IIOlympus America, Inc. / cleared 2012-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)