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U.S. Department of Health and Human Services

Class 2 Device Recall Xper Flex Cardio Physiomonitoring System

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 Class 2 Device Recall Xper Flex Cardio Physiomonitoring Systemsee related information
Date Initiated by FirmAugust 03, 2018
Create DateSeptember 18, 2018
Recall Status1 Terminated 3 on July 15, 2021
Recall NumberZ-3192-2018
Recall Event ID 80761
510(K)NumberK101571 
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
ProductXper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Code Information 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 
Recalling Firm/
Manufacturer		 Invivo Corporation
12151 Research Pkwy Ste 200
Orlando FL 32826-3286
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionPhilips 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 Commerce38
DistributionDistribution in the Netherlands
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MWI
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