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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus

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  Class 2 Device Recall Olympus see related information
Date Initiated by Firm January 20, 2016
Create Date February 25, 2016
Recall Status1 Terminated 3 on October 13, 2016
Recall Number Z-0892-2016
Recall Event ID 73088
Product Classification Endoscope, flexible - Product Code GCQ
Product Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
Code Information Serial Numbers: 2203925,2001221,2205721,2102757,2102758,2000420,2419219,2001053,2001248,2001285, 2103701,2307844,2408213,2419900,2419587,2419391,2307188,2408135,2408138,2205035, 2205321,2306154,2103419,2000710,2408319,2103515,2204385,2204384,2510491,2419538, 2001154,2103711,2101909,2306353,2103416,2000041,2103345,2408554,2408663,2307057, 2103617,2419115,2306153,2205297,2205019,2306510,2419520,2000431,2408693,2205441, 2419920,2204907,2102886,2102877,2306758,2306495,2000590,2510424,2205820,2307047, 2307014,2307030,2307052,2307066,2306132,2204209,2204663,2204110,2419379,2205371, 2205380,2205384,2408566,2204782,2103708,2101363,2419549,2001300,2103162,2103161, 2510637,2419320,2204264,2204882,2408764,2408487,2419319,2510526,2204325,2419745, 2204606,2103269,2102524,2419255,2419198,2204551,2000906,2307366,2307304,2103274, 2510151,2419258,2102792,2307251,2102786,2307350,2419462,2407416,2306959,2306800, 2307470 
Recalling Firm/
Manufacturer		 Integrated Medical Systems Inc
3200 2nd Ave N
Birmingham AL 35222-1212
For Additional Information Contact Ms. Kathryn E. Cadorette
205-244-1743
Manufacturer 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.
FDA Determined
Cause 2		 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 111 instruments
Distribution Distributed US (nationwide) and in Australia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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