Z-0462-2019Class II

Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

Name: Z-0462-2019 Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Creator: Invivo Corporation
Published: 2018-09-24
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2018-09-24 / Completed / root cause: software

FDA source

Invivo Corporation began a recall of Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 on 2018-09-24. FDA classified it as Class II and gives the reason as "The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-0462-2019
Classification: Class II
Status: Completed
Initiated: 2018-09-24
Posted: 2018-11-14
Recalling firm: Invivo Corporation
Product: Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard
Root cause tag: software
FDA root cause: Software Design Change
Action: Customers were notified on about 09/20/2018 via an "URGENT - Medical Device Correction" letter. An initial letter was sent to distributors with instructions to provide the Field Safety Notice to all customers the devices were further distributed to. The "URGENT - Medical Device Correction" letter provided guidance on how to identify the Service Number and serial number on the Flex Cardio device, which is on the bottom right corner of the back of the device. Actions to be taken by the customer/user until Philips contacts the customer to arrange for a software update to address this issue, is if the IBP numeric values become frozen and do not update in real-time, opening the Waveform Setup Dialog and then immediately pressing the OK button will restore the proper display of the IBP numeric values. Alternative methods of performing the functions listed in the Problem Description section that do not cause the problem to occur include the following: 1. Change an IBP Site Label using the Pressure Setup Dialog or a macro; 2. Activate or deactivate the mean pressure waveform display option (On/Off) by using the Waveform Setup Dialog, the Pressure Setup Dialog or a macro; 3. Activate or deactivate the waveform hide option (On/Off) using the Waveform Setup Dialog, the Pressure Setup Dialog, the keyboard or a macro; 4. Activate or deactivate the pressure waveform filter option (On/Off) using a macro. A Philips representative will contact each customer regarding their affected Flex Cardio devices. A software update will be required on both the affected Flex Cardio device and on the host workstations driver. These actions will be implemented free of charge by Philips.
Quantity in commerce: 76 units
Distribution: Distributed to the Netherlands
Product codes and lots: Model Number 453564669081; System Serial Number (UDI): US1814000001 ((01)00884838091474(21)US1814000001), US1814000002 ((01)00884838091474(21)US1814000002), US1814000003 ((01)00884838091474(21)US1814000003), US1814000004 ((01)00884838091474(21)US1814000004), US1814000006 ((01)00884838091474(21)US1814000006), US1814000007 ((01)00884838091474(21)US1814000007), US1814000008 ((01)00884838091474(21)US1814000008), US1814000011 ((01)00884838091474(21)US1814000011), US1814000012 ((01)00884838091474(21)US1814000012), US1814000013 ((01)00884838091474(21)US1814000013), US1814000014 ((01)00884838091474(21)US1814000014), US1814000016 ((01)00884838091474(21)US1814000016), US1814000017 ((01)00884838091474(21)US1814000017), US1814000018 ((01)00884838091474(21)US1814000018), US1814000019 ((01)00884838091474(21)US1814000019), US1814000020 ((01)00884838091474(21)US1814000020), US1814000022 ((01)00884838091474(21)US1814000022), US1814000023 ((01)00884838091474(21)US1814000023), US1814000024 ((01)00884838091474(21)US1814000024), US1814000027 ((01)00884838091474(21)US1814000027), US1814000028 ((01)00884838091474(21)US1814000028), US1814000029 ((01)00884838091474(21)US1814000029), US1814000030 ((01)00884838091474(21)US1814000030), US1814000031 ((01)00884838091474(21)US1814000031), US1814000032 ((01)00884838091474(21)US1814000032), US1814000033 ((01)00884838091474(21)US1814000033), US1814000034 ((01)00884838091474(21)US1814000034), US1814000035 ((01)00884838091474(21)US1814000035), US1814000036 ((01)00884838091474(21)US1814000036), US1814000037 ((01)00884838091474(21)US1814000037), US1814000038 ((01)00884838091474(21)US1814000038), US1814000039 ((01)00884838091474(21)US1814000039), US1814000040 ((01)00884838091474(21)US1814000040), US1814000041 ((01)00884838091474(21)US1814000041), US1814000043 ((01)00884838091474(21)US1814000043), US1814000044 ((01)00884838091474(21)US1814000044), US1814000045 ((01)00884838091474(21)US1814000045), US1814000046 ((01)00884838091474(21)US1814000046), US1814000047 ((01)00884838091474(21)US1814000047), US1814000048 ((01)00884838091474(21)US1814000048), US1814000049 ((01)00884838091474(21)US1814000049), US1814000050 ((01)00884838091474(21)US1814000050), US1814000051 ((01)00884838091474(21)US1814000051), US1814000052 ((01)00884838091474(21)US1814000052), US1814000053 ((01)00884838091474(21)US1814000053), US1814000054 ((01)00884838091474(21)US1814000054), US1814000055 ((01)00884838091474(21)US1814000055), US1814000056 ((01)00884838091474(21)US1814000056), US1814000058 ((01)00884838091474(21)US1814000058), US1814000059 ((01)00884838091474(21)US1814000059), US1814000060 ((01)00884838091474(21)US1814000060), US1814000061 ((01)00884838091474(21)US1814000061), US1814000062 ((01)00884838091474(21)US1814000062), US1814000063 ((01)00884838091474(21)US1814000063), US1814000064 ((01)00884838091474(21)US1814000064), US1814000065 ((01)00884838091474(21)US1814000065), US1814000066 ((01)00884838091474(21)US1814000066), US1814000067 ((01)00884838091474(21)US1814000067), US1814000068 ((01)00884838091474(21)US1814000068), US1814000069 ((01)00884838091474(21)US1814000069), US1814000070 ((01)00884838091474(21)US1814000070), US1814000072 ((01)00884838091474(21)US1814000072), US1814000074 ((01)00884838091474(21)US1814000074), US1814000078 ((01)00884838091474(21)US1814000078), US1814000081 ((01)00884838091474(21)US1814000081), US1814000082 ((01)00884838091474(21)US1814000082), US1814000083 ((01)00884838091474(21)US1814000083), US1814000084 ((01)00884838091474(21)US1814000084), US1814000085 ((01)00884838091474(21)US1814000085), US1814000086 ((01)00884838091474(21)US1814000086), US1814000087 ((01)00884838091474(21)US1814000087), US1814000088 ((01)00884838091474(21)US1814000088), US1814000089 ((01)00884838091474(21)US1814000089), US1814000092 ((01)00884838091474(21)US1814000092), US1814000094 ((01)00884838091474(21)US1814000094), US1814000096 ((01)00884838091474(21)US1814000096).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0462-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0462-2019	Class II	Completed	Voluntary: Firm initiated	2018-11-21	2018-11-14

Product code DQK

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)