Integrated Medical Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-0908-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

Product Classification:

Class II

Date Initiated: January 20, 2016

Date Posted: March 2, 2016

Recall Number: Z-0908-2016

Event ID: 73088

Reason for Recall:

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Status: Terminated

Product Quantity: 1 instrument

Code Information:

Serial Number 2303917

Distribution Pattern:

Distributed US (nationwide) and in Australia.

Voluntary or Mandated:

Voluntary: Firm initiated