Z-3192-2018Class II

Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

Name: Z-3192-2018 Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Creator: Invivo Corporation
Published: 2018-08-03
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2018-08-03 / Terminated / root cause: software

FDA source

Invivo Corporation began a recall of Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 on 2018-08-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3192-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-03
Posted: 2018-09-18
Terminated: 2021-07-15
Recalling firm: Invivo Corporation
Product: Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Philips is asking customers to follow the Action to be Taken by Customer/User section of the August 3, 2018, Field Safety Notice: The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will replace all affected devices. Users should discontinue use of affected devices immediately. A Philips representative will contact you regarding your affected device.
Quantity in commerce: 38
Distribution: Distribution in the Netherlands
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3192-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3192-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-18

Product code MWI

K101571Class IIXper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp / cleared 2010-10-26

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)