CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report

Xper Flex Cardio Physiomonitoring System recalled by Invivo

Invivo is recalling Xper Flex Cardio Physiomonitoring System. The recall was initiated on 3 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem 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

Quantity recalled38

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3192-2018
FDA event ID: 80761
Recalling firm: Invivo, Orlando, FL
Classification: Class II
Status: Terminated
Recall initiated: 3 Aug 2018
FDA classified: 18 Sep 2018
Reported: 26 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Patient Monitors

Timeline

3 Aug 2018	Recall initiated by company
18 Sep 2018	Classified by FDA	+46 days
26 Sep 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

Where it was distributed

Distribution in the Netherlands

Questions about this recall

Is Xper Flex Cardio Physiomonitoring System recalled?

Yes. Invivo recalled Xper Flex Cardio Physiomonitoring System on 3 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-3192-2018.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Distribution in the Netherlands

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Invivo

All 18

Reported	Class	Recall	Company	Reason	Where
28 Oct 2020Device	CLASS III	MR Coils The MR Coil is intended to be used recalled by Invivo	Invivo	Other	Nationwide
11 Mar 2020Device	CLASS II	Monitor for the Functional Imaging System recalled by Invivo	Invivo	Other	17 states
21 Nov 2018Device	CLASS II	Xper Flex Cardio Physiomonitoring System recalled by Invivo	Invivo	Device Malfunction	FL
13 Jun 2018Device	CLASS II	Xper Flex Cardio Physiomonitoring System The Xper Flex recalled	Invivo	Temperature Abuse	Nationwide
11 Apr 2018Device	CLASS II	DynaCad software consist of an MR Analysis Server software recalled	Invivo	Packaging Defects	FL

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