Z-0263-2018Class II

Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular...

Name: Z-0263-2018 Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular...
Creator: Invivo Corporation
Published: 2017-08-18
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2017-08-18 / Terminated / root cause: software

FDA source

Invivo Corporation began a recall of Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such on 2017-08-18. FDA classified it as Class II and gives the reason as "Intermittent communication between the host system and the FlexCardio". 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-0263-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-18
Posted: 2017-12-19
Terminated: 2024-09-20
Recalling firm: Invivo Corporation
Product: Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Intermittent communication between the host system and the FlexCardio
Root cause tag: software
FDA root cause: Software Design Change
Action: On August 24, 2017 Philips send the following communications to distributors and clients. Dear Distributor, Philips is initiating an action related to the Xper Flex Cardio Patient Monitoring System. The attached Field Safety Notice is intended to inform customers about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients, users or servicers " the actions planned by Philips to correct the problem. It is imperative that all affected end users of the Xper Flex Cardio receive the attached Field Safety Notice. Because Philips sells these products through distributors, including your organization, we may not have the information necessary to contact all end users. Therefore, please send the attached Field Safety Notice to each customer to whom you have distributed one of the affected devices. A description of the affected device can be found in the Field Safety Notice attached. -- Dear Customer, A problem has been detected in the Philips Xper Flex Cardio Patient Monitoring System (Flex Cardio) that, if it were to recur, could pose a risk for patients or users. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. Because of intermittent communication between the host system and the Flex Cardio, it is possible for any of the following conditions to occur, which could result in delays in diagnosis or treatment: " Boom Monitor (display) may not display all active waveform and/or vital sign data. " Delayed audible and visual alarms at the Flex Cardio and Boom Monitor respectively, due to a mismatch between the alarm limits on the host system and the Flex Cardio/Boom Monitor. " After patient admission and ca
Quantity in commerce: 4,535
Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Puerto Rico Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bulgaria, Cambodia, Canada, Cayman Island, Chile, China, Colombia, Congo, Cote D'Ivoire, Cuba, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Papua, Paraguay, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Yemen
Product codes and lots: All Flex Cardio devices, Revision A, B Code Number's: 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335 and 860338

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0263-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0263-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-19

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)