ClearanceBrief
Recall Z-2583-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Philips Healthcare Inc.

Philips SureSigns VM Series Patient Monitors: VM4, VM6, VM 8: Model Part Numbers VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971 VM6 863064, 863065, 453564024421, 453564022001, 453564024441, 453564022041 VM8 863066, 863068, 453564022081, 453564024461, 453564024481 The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professiona

DateJun 17, 2011 (initiated Jun 10, 2011)
StatusTerminated
ReasonSpeakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a Speaker Malfunc message in the alarm message area or an AUDIO FAILED message in the main screen of the device or by the absence of audible sound
Root causeDevice Design
ActionPhilips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 2011 to all affected customers. The letter identifies the products, problem, and actions to be taken. The letter states that customers may continue to use the affected products while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP. Additionally, the letter states that if the customer experience this INOP or there is no sound from the SureSigns Monitor, the customer is to remove the device from use and contact their local Philips service
Quantity515 units
DistributionWorldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K101067SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068
Philips Medical Systems, May 7, 2010