FDA Device recall Z-2760-2016
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet…
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet… by Invivo, citing display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2760-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-19 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Invivo |
| Distribution | US |
Product
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
Reason
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
Identifiers
| code_info | Product: Xper Flex Cardio Patient Monitoring System Model Numbers FC2010 and FC2020 Serial Numbers by Product: 45356…Product: Xper Flex Cardio Patient Monitoring System Model Numbers FC2010 and FC2020 Serial Numbers by Product: 453564241901 USI203010414 USI244000011 USI234000052 USI521000021 USI343000067 USI343000030 USI337000084 USI334000030 USI331000048 US 1328000004 USI324000049 USI324000017 USI319000088 US1319000043 USI319000016 USI251000082 USI251000054 USI251000042 USI251000007 USI25000054 USI248000041 USI234000090 USI224000028 USI203010318 USI202010188 USI343000053 USI251000005 USI231000001 US1334000034 USI334000018 USI319000053 USI234000045 us 1343000064 us 1343000018 us 1334000026 us 1334000008 USI324000025 USI311000001 USI239000005 USI234000054 USI224000026 USI203010419 USI203010418 USI203010411 USI203010403 USI203010391 US1203010372 USI203010301 US120301 0256 USI20201 0209 USII0701 0022 USI343000015 USI334000028 USI319000077 USI337000059 US1337000022 USI33!000014 USI319000087 USI319000061 US1319000002 USI244000002 USI239000049 USI203010392 USI203010264 US1201010131 USI1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2760-2016%22
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