Home / Recalls / Integrated Medical Systems Inc / Z-0897-2016

Z-0897-2016 Class II Terminated

Recalled by Integrated Medical Systems Inc — Birmingham, AL

Recall Details

Product Type
Devices
Report Date
March 2, 2016
Initiation Date
January 20, 2016
Termination Date
October 13, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 instruments

Product Description

Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

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.

Distribution Pattern

Distributed US (nationwide) and in Australia.

Code Information

Serial Numbers: 2123053,2337714,2338700,2337727,2112612

Other recalls by Integrated Medical Systems Inc

  • Z-0890-2016 Class II — Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope (January 20, 2016)
  • Z-0904-2016 Class II — Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope (January 20, 2016)
  • Z-0896-2016 Class II — Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope (January 20, 2016)
  • Z-0902-2016 Class II — Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope (January 20, 2016)
  • Z-0893-2016 Class II — Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope (January 20, 2016)
  • Z-0908-2016 Class II — Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric co (January 20, 2016)
  • Z-0901-2016 Class II — Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope (January 20, 2016)
  • Z-0905-2016 Class II — Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope (January 20, 2016)
  • Z-0889-2016 Class II — Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric c (January 20, 2016)
  • Z-0894-2016 Class II — Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope (January 20, 2016)