Z-1326-2021Class II

Philips SureSigns VM4, VM6 and VM8 -

Name: Z-1326-2021 Philips SureSigns VM4, VM6 and VM8 -
Creator: Philips North America, LLC
Published: 2021-03-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-03-23 / Terminated / root cause: software

FDA source

Philips North America, LLC began a recall of Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults... on 2021-03-23. FDA classified it as Class II and gives the reason as "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...". 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-1326-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-23
Posted: 2021-03-30
Terminated: 2023-09-28
Recalling firm: Philips North America LLC
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
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Software version: SW A.02.63

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1326-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1326-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-30

Product code MHX

K123900Class IISuresigns Vm4, Suresigns Vm6, Suresigns Vm8Philips Medical Systems / cleared 2013-04-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)