FDA Device recall Z-2892-2018
Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and…
- FDA Device
- Class II
- ongoing
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class II recall of Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and… by Philips Electronics North America, citing 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 shoul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2892-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-07-13 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
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
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 to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
Identifiers
| code_info | UDI# VSV (863067): 00884838009578 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2892-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.