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U.S. Department of Health and Human Services

Class 2 Device Recall SureSigns VM4, VM6, and VM8 patient monitors

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  Class 2 Device Recall SureSigns VM4, VM6, and VM8 patient monitors see related information
Date Initiated by Firm March 23, 2021
Create Date March 30, 2021
Recall Status1 Terminated 3 on September 28, 2023
Recall Number Z-1326-2021
Recall Event ID 87418
510(K)Number K123900  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only)

SureSigns VM4 (863063, 863085)
SureSigns VM6 (863064, 863065, 863086)
SureSi"gns VM8 (863066, 863068, 863087, 863088)

Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421
453564024441,453564024461, 453564024481
Code Information Software version: SW A.02.63
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer Reason
for Recall		 Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products will be lower than this upper limit
FDA Determined
Cause 2		 Software design
Action Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter issued on 3/23/21 , stating: Reason for correction, health risk and Action to be Taken by Customer/User states: This issue only happens on pediatric type patient with heartrate is greater than device claimed maximum heart rate 300 bpm. The device can continue to be used, however when using the monitor in the Pediatric category, patients at risk for tachycardia should be kept under close observation in accordance with existing product warnings described in the IFU. You may also consider to keep the default HR alarm limits or set tight HR alarm limits around the patients baseline HR for these patients Philip will send an engineer onsite to check the SW revision of your monitors. PHILIPS Subsequently a SW upgrade will be performed if your device is with the affected software revision. A Philips Healthcare representative will contact you to arrange for the correction.
Quantity in Commerce 31773 units
Distribution International distribution in the country of China.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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