Philips Healthcare Inc. SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4" display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4" display or 3/5 Lead ECG, NBP, Temp, optional SPo2 option IBP Bedside Patient Monitor with 8.4" display VM8 3/5 Lead ECG, NBP, Temp, IPB, ET CO2 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4" display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4" display or 3/5 Lead ECG, NBP, Temp, optional SPo2 option IBP Bedside Patient Monitor with 8.4" display VM8 3/5 Lead ECG, NBP, Temp, IPB, ET CO2
Brand
Philips Healthcare Inc.
Lot Codes / Batch Numbers
Software Versions: A.01.51, A.01.45, A.01.42, A.01.40, A.00.58, A.00.55, A.00.52, A.00.51, and A.00.41
Products Sold
Software Versions: A.01.51, A.01.45, A.01.42, A.01.40, A.00.58, A.00.55, A.00.52, A.00.51, and A.00.41
Philips Healthcare Inc. is recalling SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Pa due to Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker
Recommended Action
Per FDA guidance
Customer notifications dated October 2009, in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be instructed to lower the volume setting while using existing units during the first notification. As part of the second notification to the customers, the field action correction will be a customer installable software upgrade. Customers may contact Philips Response Center with questions or concerns at 1.800.722.9377. On December 14, the firm issued the follow-up notification letter implementing the action plan to provide the software upgrade kit for installation and instructions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026