Device product
Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
Z-0201-2015
Product summary
- Event
- Event 69251
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43 (LCX02) and 17 (LCX02R)
- Official record key
device-enforcement:Z-0201-2015
Official wording
Reason: Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.
Code information: Catalogue #LCX02 - Serial #'s 2130901032, 2130901050, 2131001062, 2131001063, 2131001086, 2131001087, 2131001102, 2131001110, 2131001111, 2131001115, 2131101124, 2131101125, 2131101127, 2131101129, 2131101134, 2131101138, 2131101151, 2131101154, 2140101181, 2140301222, 2130901017, 2130901019, 2130901022, 2130901025, 2130901034, 2130901035, 2130901051, 2130901055, 2130901056, 2130901058, 2130901059, 2131001072, 2131001076, 2131001077, 2131001081, 2131001088, 2131001093, 2131001108, 2131101126, 2131101129, 2131101122, 2130901028 and 2130901039; Catalogue #LCX02R - Serial #'s 2130901038, 2130901046, 2130901054, 2131201163, 2131201164, 2131201165, 2131201166, 2131201167, 2140101170, 2140101172, 2140101174, 2140101178, 2140101179, 2140201186, 2140201189, 2140201197 and 2140401227.
Distribution pattern: US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX
Derived failure modes
-
Unknown
Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.