Date Initiated by Firm | December 04, 2015 |
Date Posted | January 13, 2016 |
Recall Status1 |
Terminated 3 on March 31, 2016 |
Recall Number | Z-0644-2016 |
Recall Event ID |
72915 |
Product Classification |
System, digital image communications, radiological - Product Code LMD
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Product | Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. |
Code Information |
Lot# T9993-02-01 /15924CARTXXTNNA / DX00357 Lot# T9993-02-02 / 15924CARTXXAZPH / DX00358 Lot# U0328-02-02 / 15A01CARTXXCOEN /DX00360 Lot# U0328-02-01 / 15A26CARTXXCAK1 / DX00359 Lot# U0718-02-01 / 15A26CARTXXCAK2 / DX00361 Lot# U0718-02-02 / 15A26CARTXXCAK3 / DX00362 Lot# U1033-02-01 / 15A19CARTXXOHCA /DX00363 Lot# U1033-02-02 / 15A26CARTXXCASJ / DX00364 Lot# U1126-02-01 / 15A26CARTXXCAK41 /DX00365 Lot# U1126-02-02 / 15806CARTXXGAAT / DX00366 |
Recalling Firm/ Manufacturer |
CompView Medical, LLC 2818 E 2nd St Suite 200 Vancouver WA 98661-7778
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For Additional Information Contact | Christine Breitbach 503-601-5603 |
Manufacturer Reason for Recall | The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release and detach. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | The firm began inspecting devices between 12/4/15 and 12/16/15, and sent the Nucart Product Investigation letter to consignees between 12/11/15 and 12/15/15.
Consignees with questions can call the firm at 503-601-5603. |
Quantity in Commerce | 10 units |
Distribution | US nationwide distribution including AZ, CA, CO, GA, OH, and TN. |
Total Product Life Cycle | TPLC Device Report |
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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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