Z-0889-2016Class II

Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

Name: Z-0889-2016 Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
Creator: Integrated Medical Systems Inc
Published: 2016-01-20
License: https://open.fda.gov/license/

Integrated Medical Systems Inc / initiated 2016-01-20 / Terminated / root cause: manufacturing process

FDA source

Integrated Medical Systems Inc began a recall of Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope on 2016-01-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0889-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-20
Posted: 2016-02-25
Terminated: 2016-10-13
Recalling firm: Integrated Medical Systems Inc
Product: Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
Product code: GCQ Endoscope, Flexible
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm notified their consignees of the issue by Fed Ex on 01/20/2016. The firm plans to coordinate with the medical facilities for inspection of the endoscopes.
Quantity in commerce: 190 instruments
Distribution: Distributed US (nationwide) and in Australia.
Product codes and lots: Serial Numbers: 2005030,2800270,2007268,2802306,2802294,2108696,2801707,2006928,2201349,2904573, 2108936,2006513,2107568,2801235,2800468,2200301,2006896,2802237,2802245,2109496, 2109225,2006520,2200358,2200372,2200370,2200350,2200356,2200364,2200351,2200345, 2005915,2109239,2109237,2904265,2108385,2100007,2904378,2801427,2200930,2107811, 2700057,2004864,2004924,2800273,2109999,2100088,2301603,2107560,2200701,2200648, 2904362,2802353,2802234,2801828,2801792,2903393,2903491,2109241,2109087,2109090, 2201179,2109261,2109234,2802808,2801887,2801892,2007452,2801960,2006598,2903718, 2007242,2007253,2903751,2006554,2006560,2802465,2007275,2004893,2802541,2903876, 2903913,2200971,2700124,2904046,2904425,2007142,2802500,2904240,2109319,2800517, 2802466,2802455,2200168,2006418,2200172,2006479,2108689,2201411,2201402,2005274, 2005123,2005141,2201410,2201389,2903348,2800505,2006883,2801725,2200481,2903648, 2903632,2108188,2108969,2109228,2109233,2802031,2802017,2802028,2802016,2802029, 2108350,2108320,2801583,2903806,2904150,2007033,2903029,2802758,2802794,2802793, 2005497,2005545,2700076,2903964,2903965,2903969,2201427,2100108,2007401,2802654, 2005642,2802394,2903060,2903059,2903756,2200703,2200988,2201112,2903499,2904701, 2802756,2005665,2800338,2108452,2100110,2201023,2301893,2301911,2904358,2904345, 2904344,2904356,2904336,2802111,2005706,2005255,2200750,2200766,2200880,2200769, 2200774,2005599,2802920,2006131,2006639,2006641,2006642,2006638,2006640,2006632, 2006628,2006635,2006634,2903927,2005006,2904212,2903346,2802333,2904016,2903343

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0889-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0889-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0890-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0891-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0892-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0893-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0894-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0895-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0896-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0897-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0898-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0899-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0900-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0901-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0902-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0903-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0904-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0905-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0906-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0907-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0908-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0909-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25
Z-0910-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25

Product code GCQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)