—#86327

Product

SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predictive Temperature only; SPo2 only; SPo2 and Recorder only; SPo2 and Predictive Temperature only; or SPo2, Predictive Temperature, and Recorder Part Number: 863067 and 453564041491 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K090483
Affected lot / code info: Software Versions: A.00.48, and A.00.4O

Why it was recalled

Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Nationwide Foreign: Canada Afghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, Ghana, Great Britain, French Guiana, Guadeloupe, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Iraq, Jordan, Japan, Jamaica Republic of Korea, Kenya, Kosovo, Kuwait, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Libyan Arab Jamahiriya, Morocco, Norway, New Zealand, Republic of Moldova, Macau, Malawi, Mali, Malta, Martinique, Mauritius, Mexico, Malaysia, Namibia, Nepal, Netherlands,Nicaragua, Nigeria, Norway, Philippines, Pakistan, Oman, Panama, Peru, Poland, Puerto Rico, Palestinian Territories, Portugal, Qatar, Romania, Republic of Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Spain, Sri Lanka, Switzerland, El Salvador, Tanzania, Thailand, Tunisia, Turkey, Taiwan, Uganda, Venezuela, Vietnam, South Africa, and Zimbabwe United Arab Emirates

Timeline

Recall initiated: 2009-10-30
Posted by FDA: 2009-11-23
Terminated: 2013-02-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86327. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.