Philips Electronics North America Corporation Recall: Philips SureSigns VSV (Vital Signs V
Philips Electronics North America Corporation Recall: Philips SureSigns VSV (Vital Signs V is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Electronics North America Corporation; Product: Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of mult
| Recalling firm | Philips Electronics North America Corporation |
|---|---|
| Product | 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. |
| Reason for recall | 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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, |
| Recall initiated | 20180713 |
| Recall number | Z-2892-2018 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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