CLASS II ONGOING Device recall · Reported 13 Jun 2018 · FDA Enforcement Report

Xper Flex Cardio Physiomonitoring System The Xper Flex recalled

Invivo is recalling Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is, distributed nationwide in the US. The recall was initiated on 20 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMODEL #(s): 453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375, US1203010398, US1203010407, US1304000043, US1304000046, US1224000050, US1550001470, US1251000063, US1109010070, US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396, US1231000007, US1231000032, US1231000050, US1231000074, US1231000090, US1234000008, US1311000016, US1311000023, US1248000071, US1708000101, US1720000441, US1550001478, US1248000065, US1729000603, US1352000006, US1352000022, US1352000044, US1352000046, US1352000048, US1107010005, US1231000060, US1537001268, US1537001272, 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US1505000482. US1505000502. 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US1623002117, US1624002199, US1224000035, US1201010128, US1720000448, and US1224000013

Quantity recalled1,040 units (USA) and 7 units (Foreign)

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-2115-2018
FDA event ID: 80057
Recalling firm: Invivo, Orlando, FL
Classification: Class II
Status: Ongoing
Recall initiated: 20 Nov 2017
FDA classified: 7 Jun 2018
Reported: 13 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Heart & Vascular Devices

Timeline

20 Nov 2017	Recall initiated by company
7 Jun 2018	Classified by FDA	+199 days
13 Jun 2018	Published in enforcement report	+6 days

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

Reason for recall

While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.

Where it was distributed

Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.

Nationwide Alaska Alabama Arkansas Arizona California Connecticut District of Columbia Florida Georgia Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Missouri North Carolina

Questions about this recall

Is Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is recalled?

Yes. Invivo recalled Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is on 20 Nov 2017. The recall is Class II and its status is Ongoing. Recall number Z-2115-2018.

Why was it recalled?

Which lots are affected?

MODEL #(s): 453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375, US1203010398, US1203010407, US1304000043, US1304000046, US1224000050, US1550001470, US1251000063, US1109010070, US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396, US1231000007, US1231000032, US1231000050, US1231000074, US1231000090, US1234000008, US1311000016, US1311000023, US1248000071, US1708000101, US1720000441, US1550001478, US1248000065, US1729000603, US1352000006, US1352000022, US1352000044, US1352000046, US1352000048, US1107010005, US1231000060, US1537001268, US1537001272, US1537001276, US1537001277, 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Where was it sold?

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
26 Sep 2018Device	CLASS II	Xper Flex Cardio Physiomonitoring System recalled by Invivo	Invivo	Labeling Errors	FL
11 Apr 2018Device	CLASS II	DynaCad software consist of an MR Analysis Server software recalled	Invivo	Packaging Defects	FL

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide