Recall Z-1326-2021 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America, LLC
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: 863063,863064,863065,863066,863068,863085,8
| Date | Mar 23, 2021 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 31773 units |
| Distribution | International distribution in the country of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123900 | SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 Philips Medical Systems, Apr 18, 2013 |