Recall Z-2892-2018 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
| Date | Jul 13, 2018 |
| Status | Open, Classified |
| Reason | Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case |
| Root cause | Labeling design |
| Action | On July 13, 2018, the firm issued an "URGENT-Medical Device Correction" letter dated July 10, 2018, to affected customers to advise them that that monitors with batteries that have exceeded their specified replacement interval may overheat or ignite. The firm issued a Service Guide addendum included with the letter, which contains information to assist with managing the battery and its replacement. Customers were advised to do the following: Upon receipt of this notification, carefully read the enclosed SureSigns Addendum to the Service Guide. VS Series Customers -Addendum to the Service Gu |
| Quantity | VM 96,324 Units; VS 110,424 Units; VSV 691 Units |
| Distribution | Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Czech Republic, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070588 | PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) Philips Medical Systems, Mar 20, 2007 |