Z-0644-2016Class II

Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive...

Name: Z-0644-2016 Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive...
Creator: CompView Medical, LLC
Published: 2015-12-04
License: https://open.fda.gov/license/

CompView Medical, LLC / initiated 2015-12-04 / Terminated / root cause: manufacturing process

FDA source

CompView Medical, LLC began a recall of Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing... on 2015-12-04. FDA classified it as Class II and gives the reason as "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". 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-0644-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-04
Posted: 2016-01-13
Terminated: 2016-03-31
Recalling firm: CompView Medical, LLC
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.
Product code: LMD System, Digital Image Communications, Radiological
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0644-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0644-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-13

Product code LMD

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)