Home / Recalls / Invivo Corporation / Z-3192-2018

Z-3192-2018 Class II Terminated

Recalled by Invivo Corporation — Orlando, FL

Recall Details

Product Type
Devices
Report Date
September 26, 2018
Initiation Date
August 3, 2018
Termination Date
July 15, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38

Product Description

Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

Reason for Recall

Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.

Distribution Pattern

Distribution in the Netherlands

Code Information

System Serial Numbers: US1814000001, US1814000002, US1814000003, US1814000004, US1814000006, US1814000007, US1814000008, US1814000011, US1814000012, US1814000013, US1814000014, US1814000016, US1814000017, US1814000018, US1814000019, US1814000020, US1814000022, US1814000023, US1814000024, US1814000027, US1814000028, US1814000030, US1814000031, US1814000032, US1814000033, US1814000034, US1814000037, US1814000044, US1814000046, US1814000050, US1814000053, US1814000062, US1814000066, US1814000068,and US1814000072

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  • Z-0462-2019 Class II — Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 (September 24, 2018)
  • Z-1867-2018 Class II — PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, (March 14, 2018)
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  • Z-0082-2018 Class II — Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring (August 11, 2017)
  • Z-2688-2016 Class II — Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel (May 6, 2016)
  • Z-2760-2016 Class II — The system provides the ability to transmit patient data files for storage, view (October 19, 2015)